Anal Cancer
Conditions
Keywords
Anal Cancer, Radioprotector, Topical, Radiation, Dermatitis
Brief summary
Background: \- Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that can lead to redness and tenderness, and in some cases can be so severe that it results in blistering or peeling of the skin during treatment. These conditions cause discomfort and may require breaks from radiation treatment. Researchers are interested in determining whether MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given before radiation treatment to prevent these side effects and reduce the irritation of the skin during chemotherapy and radiation for anal cancer. Objectives: \- To determine the safety and effectiveness of topical MTS-01 given before radiation in the groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal cancer. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal and are eligible to receive radiation and chemotherapy treatments. Design: * Participants will be screened with a physical examination, medical history, blood tests, imaging studies and physical examination of the anal canal, and biopsies as needed to evaluate eligibility for treatment. * Participants will be scheduled for radiation and chemotherapy treatments on the following schedule: * Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin in the groin areas and between the buttocks before each treatment * Mitomycin C given intravenously on days 1 and 29 of treatment * 5-Fluorouracil given intravenously over 4 days (first week and fifth week) during radiation treatment * Participants will be monitored throughout the treatment for side effects, with photographs of the treatment area and frequent blood tests. * Following the end of radiation, participants will have followup visits for 1 year with blood tests and imaging studies to evaluate the response to treatment.
Detailed description
Background: * Patients with non-metastatic carcinoma of the anal canal are treated with concurrent mitomycin C (MMC), 5-fluorouracil (5-FU), and radiotherapy (RT) in the curative setting in an attempt to preserve the anal sphincter. * Radiation dermatitis is a uniform complication of this therapy which frequently results in treatment delay due to pain and discomfort. High grade dermatitis may also become superinfected in the setting of decreased blood counts from chemotherapy and diarrhea from radiation proctitis, further delaying therapy. Approaches that decrease toxicity may be particularly important in patients infected with human immunodeficiency virus (HIV). * MTS-01 (tempol, 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) is a piperidine nitroxide known to act as a chemical radioprotector with selective protection of normal versus tumor tissue. * Tempol gel (tempol 70 mg/mL plus water, ethanol, and hydroxypropyl cellulose) has been evaluated as a topical radioprotector in pilot trials that included a variety of sites. Objectives: * Primary Objective: To determine the safety and tolerability of topical MTS-01 on a daily basis prior to irradiation in the groin and gluteal cleft of patients receiving combined therapy with MMC, 5-FU, and RT for carcinoma of the anal canal. * Secondary Objectives will include evaluation of the following endpoints in a preliminary fashion: * To describe the rates and severity of skin toxicity in patients treated with this regimen * To describe the need for toxicity related treatment breaks with this regimen * To describe the opiate requirements in patients treated with this regimen * To describe 12-month progression-free survival, disease-free survival, and overall survival in patients treated with concurrent chemotherapy, radiation therapy, and MTS-01 * Evaluate the effects of antiretroviral therapy, 5-fluorouracil, mitomycin C, and radiation on low level persistent HIV viremia and HIV genetic diversity during therapy and recovery * To evaluate the feasibility of collecting HIV ribonucleic acid (RNA) and mononuclear cells from rectal associated lymphoid tissue for correlative studies * Collect and store anal cytology and core needle biopsies of tumor for future human papillomavirus infection (HPV) and tumor based analyses Eligibility: * Age greater than or equal to 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Histologically confirmed carcinoma of the anal canal without evidence of distant metastases * No contraindications to definitive chemoradiotherapy for carcinoma of the anal canal Design: This is a pilot trial of topical MTS-01 in patients receiving MMC, 5-FU, and intensity-modulated radiation therapy (IMRT) for definitive management of carcinoma of the anal canal. Fifteen patients will be enrolled. MMC will be delivered at a dose of 10mg/m(2) on days 1 and 29. 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29. RT will be delivered to a total dose of 50-54 Gy based on tumor characteristics. Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of RT. Radiation Therapy Oncology Group (RTOG) grading will be used to evaluate skin toxicity in both the groin and gluteal cleft weekly during treatment and at 4 weeks, 3 months and 6 months after completion of treatment. The duration of treatment, number of treatment breaks, opiate requirements, and level of pain will be evaluated weekly during treatment and at 4 weeks and 3 months after the completion of treatment. Disease control will be assessed at 4 weeks, 3 months, 6 months, 9 months, and 12 months of follow-up.
Interventions
DRUGTempol
Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT).
DRUG5-Fluorouracil
5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29.
DRUGMitomycin-C
Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29
PROCEDURERadiation Therapy
Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics.
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: * Histologically proven, invasive primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, stage T1-4, N0-3 * No previous therapy for anal cancer. * Age greater than or equal to 18 years * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Adequate bone marrow, renal, and hepatic function defined as * Absolute neutrophil count greater than or equal to 1,000 cells/mm(3) * Platelet count greater than or equal to 100,000/mm(3) * Hemoglobin greater than or equal to 8mg/dL * Creatinine clearance \> 60 mL/min using Cockcroft-Gault formula * Bilirubin less than or equal to 1.5 times upper limit of normal (ULN) unless, during screening, the patient is receiving protease inhibitor therapy (i.e. indinavir, ritonavir, nelfinavir, and atazanavir) known to be associated with increased bilirubin: in this case total bilirubin less than or equal to 7.5 mg/dl and the direct fraction is less than or equal to 0.7 mg/dl. * White blood cell (WBC) greater than or equal to 3,000/microL * Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to 3 times the upper limit of normal * International normalized ratio (INR) less than or equal to 1.5 * Patients of childbearing potential must be willing to use a medically effective means of birth control for the duration of treatment and six weeks after treatment. * Patients must be willing and able to provide informed consent
Exclusion criteria
* Contraindications to radiotherapy such as a history of prior radiotherapy to the pelvis or a history of inflammatory bowel disease * Prior malignancy except: * non-melanoma skin cancer * controlled Kaposi's Sarcoma (no chemotherapy for KS for 3 months, and no expected need for chemotherapy for the 12-month period of the study) * other malignancies with disease free period of at least 3 years * Presence of metastatic disease (M1) * Co-morbidity that in the estimation of the principal investigator would make the patient unable to tolerate treatment * Pregnant or lactating females * Human immunodeficiency virus (HIV) positive patients with cluster of differentiation 4 (CD4) \< 100 cells/mL AND ECOG performance status (PS) greater than 2. * Dermatitis in the anticipated radiation treatment portal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Date treatment consent signed to date off study, approximately, 36 months and 10 days. | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death related to adverse event. |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | Date treatment consent signed to date off study, approximately, 36 months and 10 days. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Treated With Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) That Required Opiates | Completion of study, approximately 14 months after start of treatment | Opiates are strong drugs prescribed by prescription used for maximum pain relief. |
| Number of Participants With 12-month Progression-free Survival Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 12 months | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. |
| Change in the Levels of Number of Human Immunodeficiency Virus (HIV) in the Circulation Pre and Post Treatment | Completion of study, approximately 14 months | Change in the levels of number of Human Immunodeficiency Virus (HIV) in the circulation pre and post treatment |
| Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | Pre-treatment and post treatment tissue (CD4), and pre-treatment and post treatment circulation (CD8) | Ratio of the number Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) cells in the circulation and tissue pre and post treatment. The number of cells of CD4 are divided by the number of cells of CD8. |
| Number of Participants With 12 Month Disease Free Survival (DFS) Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 12 months | DFS is defined as the duration of time from start of treatment to time of progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. |
| Overall Survival | start of treatment to time of death, approximately 14 months | OS is defined as the duration of time from start of treatment to time of death. |
| Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | Baseline and Course 1 Day 28 | Peripheral blood mononuclear cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor beta-1 (TGF-beta1) were sampled from peripheral blood from rectal associated lymphoid tissue to evaluate immune cell subsets at baseline and after treatment with MTS-0 and 15-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT). It is unknown if a lower or higher numbers has prognostic significance. |
| Number of Participants With Tumor Tissue Negative for Human Papilloma Virus (HPV) | Pretreatment | HPV is a sexually transmitted infection that can cause warts and cervical cancer. HPV test detects deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) of HPV in a cell sample (i.e. cervical). |
| Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | baseline, weeks 1-6, follow up at 1 week, follow up at 2 weeks, and follow up at 4 weeks | RTOG grade 1-5 were used to assess skin toxicity in the groin (right and left inguinal area) and gluteal cleft, as well as two control sites. Grade 0 is no skin toxicity, Grade 1 is follicular, faint or dull erythema, Grade 3 is tender or bright erythema, Grade 3 is confluent, moist desquamation, Grade 4 is ulceration, hemorrhage, or necrosis, and Grade 5 is death due to radiation toxicity. |
| Pain Interference | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up | The Brief Pain Inventory Scale questionnaire were used to assess pain interference. Participants rated pain interference on a scale of 0 (does not interfere) to 10 (completely interferes). |
| Mean Percentage Pain Relief After Medication | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up | The Brief Pain Inventory Scale questionnaire were used to assess pain relief after medication. Participants rated pain relief on a scale of 0% (no relief) to 100% (complete relief) and a mean and full range were reported. |
| Duration of Overall Response (DOR) | 12 months of follow up, approximately 14 months | Duration of overall response is measured from the time measurement criteria are met for Complete Response until the first date that recurrent or progressive disease is objectively document. Complete Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Complete Response is disappearance of all target lesions. |
| Percentage of Total Viable Cells That Were Cluster of Differentiation 3+ (CD3+) Cells in Biopsied Tissue | Baseline and 1 year | Percentage of total viable cells that were Cluster of differentiation 3+ (CD3+) cells in biopsied tissue. |
| Absolute Number of Cluster of Differentiation 3+ (CD3) Cells Per Gram of Biopsied Intestinal Tissue | Baseline and 1 year follow up | Absolute number of Cluster of differentiation 3+ (CD3) cells per gram of biopsied intestinal tissue. The number of CD3 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. |
| Number of Cluster of Differentiation 8+ (CD8) Cells Per Gram of Biopsied Intestinal Tissue | Baseline and 1 year follow up | Number of Cluster of differentiation 8+ (CD8) cells per gram of biopsied intestinal tissue. The number of CD8 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. |
| Number of Cluster of Differentiation 4+ (CD4) Cells Per Gram of Biopsied Intestinal Tissue | Baseline and 1 year follow up | Number of Cluster of Differentiation 4+ (CD4) cells per gram of biopsied intestinal tissue. The number of CD4 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. |
| Number of Participants With Human Immunodeficiency Virus (HIV) in Biopsy Tissue From Rectal Mucosa | Baseline and Course 1 Day 28 | Optional snag biopsies pre and post were collected from participants rectal mucosa to enumerate cell counts. |
| Brief Pain Inventory Score | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up | The Brief Pain Inventory Scale is a questionnaire that asks the participant to rate their pain on a scale of 0 (no pain) to 10 (worst pain). |
| Number of Participants That Required a Treatment Break Relative to Hematologic Toxicity (Non-dermatologic) | From beginning until completion of radiation treatment up to 46 days | Number of participants that required a treatment break relative to hematologic (e.g. thrombocytopenia, leukopenia) toxicity (non-dermatologic). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1/Chemo + Radiation Chemo + Radiation
Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT).
5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29.
Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29
Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Declined to participate before treatment started | 1 |
| Overall Study | Disease progression on study | 1 |
Baseline characteristics
| Characteristic | 1/Chemo + Radiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 55.85 years STANDARD_DEVIATION 5.16 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0 | 3 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1 | 2 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 2 | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG3 | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG4 | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 5 | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Human Immunodeficiency Virus (HIV) Status HIV Negative | 4 Participants |
| Human Immunodeficiency Virus (HIV) Status HIV Positive | 1 Participants |
| Human Papilloma Status (Anal Swab) HPV Negative | 5 Participants |
| Human Papilloma Status (Anal Swab) HPV Positive | 0 Participants |
| N Stage N0 | 4 Participants |
| N Stage N1 | 0 Participants |
| N Stage N2 | 0 Participants |
| N Stage N3 | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
| Stage I | 0 Participants |
| Stage II | 4 Participants |
| Stage IIIA | 0 Participants |
| Stage IIIB | 1 Participants |
| Stage IV | 0 Participants |
| T Stage T1 | 0 Participants |
| T Stage T2 | 2 Participants |
| T Stage T3 | 3 Participants |
| T Stage T4 | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT)
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death related to adverse event.
Time frame: Date treatment consent signed to date off study, approximately, 36 months and 10 days.
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Nausea | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Transaminitis | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoglycemia | 1 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Fatigue | 1 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary tract pain | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Radiation dermatitis | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary incontinence | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Bladder spasm | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Febrile neutropenia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Neutropenia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Lymphopenia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Abdominal pain | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Cluster of Differentiation (CD4) count decrease | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Leukopenia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Pain | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Insomnia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Diarrhea | 1 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Anemia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Infection | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Syncope | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Headache | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Gastroesophageal reflux | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Thrombocytopenia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Myalgia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypocalcemia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoalbuminemia | 0 Adverse events |
| MTS-01 Grade 1 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Mucositis | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary tract pain | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Radiation dermatitis | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Nausea | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Abdominal pain | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Diarrhea | 1 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Gastroesophageal reflux | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Mucositis | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Cluster of Differentiation (CD4) count decrease | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Bladder spasm | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary incontinence | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Fatigue | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoglycemia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Transaminitis | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoalbuminemia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypocalcemia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Myalgia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Headache | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Syncope | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Infection | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Insomnia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Pain | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Leukopenia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Lymphopenia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Neutropenia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Febrile neutropenia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Thrombocytopenia | 0 Adverse events |
| MTS-01 Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Anemia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoalbuminemia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Lymphopenia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Syncope | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Mucositis | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Leukopenia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Diarrhea | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary tract pain | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Infection | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Fatigue | 1 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Abdominal pain | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Pain | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Anemia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Insomnia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Transaminitis | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypocalcemia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoglycemia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Bladder spasm | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Gastroesophageal reflux | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Thrombocytopenia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Myalgia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Febrile neutropenia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Nausea | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Neutropenia | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary incontinence | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Headache | 0 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Cluster of Differentiation (CD4) count decrease | 1 Adverse events |
| MTS-01 Grade 3 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Radiation dermatitis | 0 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Leukopenia | 0 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Transaminitis | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoalbuminemia | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Gastroesophageal reflux | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Cluster of Differentiation (CD4) count decrease | 0 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypocalcemia | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Myalgia | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Thrombocytopenia | 2 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Headache | 0 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Diarrhea | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Syncope | 0 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Radiation dermatitis | 2 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Infection | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Insomnia | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Abdominal pain | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Pain | 2 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Anemia | 3 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoglycemia | 0 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Lymphopenia | 0 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Nausea | 3 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Neutropenia | 2 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary tract pain | 2 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Bladder spasm | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary incontinence | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Fatigue | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Mucositis | 1 Adverse events |
| 5FU/MMC/IMRT Grade 2 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Febrile neutropenia | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Thrombocytopenia | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary incontinence | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Lymphopenia | 5 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Mucositis | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Headache | 1 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Diarrhea | 2 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Transaminitis | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Neutropenia | 3 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Urinary tract pain | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Febrile neutropenia | 1 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Myalgia | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypocalcemia | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoglycemia | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Bladder spasm | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Insomnia | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Hypoalbuminemia | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Cluster of Differentiation (CD4) count decrease | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Abdominal pain | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Radiation dermatitis | 3 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Pain | 2 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Infection | 1 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Gastroesophageal reflux | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Syncope | 1 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Fatigue | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Leukopenia | 5 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Nausea | 0 Adverse events |
| 5-FU/MMC/IMRT Grade 3-4 | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Anemia | 0 Adverse events |
Primary
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately, 36 months and 10 days.
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MTS-01 Grade 1 | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | 5 Participants |
Secondary
Absolute Number of Cluster of Differentiation 3+ (CD3) Cells Per Gram of Biopsied Intestinal Tissue
Absolute number of Cluster of differentiation 3+ (CD3) cells per gram of biopsied intestinal tissue. The number of CD3 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue.
Time frame: Baseline and 1 year follow up
Population: 1/6 participants enrolled withdrew before treatment. 3 participants underwent optional biopsy.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Absolute Number of Cluster of Differentiation 3+ (CD3) Cells Per Gram of Biopsied Intestinal Tissue | Baseline | 22.98 CD3+cells/gm tissue(x 10^5) |
| MTS-01 Grade 1 | Absolute Number of Cluster of Differentiation 3+ (CD3) Cells Per Gram of Biopsied Intestinal Tissue | 1 year follow up | 13.62 CD3+cells/gm tissue(x 10^5) |
Secondary
Brief Pain Inventory Score
The Brief Pain Inventory Scale is a questionnaire that asks the participant to rate their pain on a scale of 0 (no pain) to 10 (worst pain).
Time frame: Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Brief Pain Inventory Score | Worst pain at baseline | 4.8 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Worst pain at treatment week 3 | 3.5 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Worst pain at treatment week 6 | 7.2 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Worst pain at 1 month follow up | 3.1 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Worst pain at 3 months follow up | 2.1 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Least pain at baseline | 1.4 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Least pain at treatment week 3 | 1.5 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | least pain at treatment week 6 | 3.6 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Least pain at 1 month follow up | 1.2 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Least pain at 3 months follow up | 2.8 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Average pain at baseline | 1.8 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Average pain at treatment week 3 | 1.9 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Average pain at treatment week 6 | 5.0 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Average pain at 1 month follow up | 2.0 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Average pain at 3 months follow up | 3.0 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Pain at time of survey at baseline | 1.6 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Pain at time of survey at treatment week 3 | 1.3 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Pain at time of survey at treatment week 6 | 5.4 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Pain at time of survey a 1 month follow up | 2.2 Scores on a scale |
| MTS-01 Grade 1 | Brief Pain Inventory Score | Pain at time of survey at 3 months follow up | 2.2 Scores on a scale |
Secondary
Change in the Levels of Number of Human Immunodeficiency Virus (HIV) in the Circulation Pre and Post Treatment
Change in the levels of number of Human Immunodeficiency Virus (HIV) in the circulation pre and post treatment
Time frame: Completion of study, approximately 14 months
Population: The participants were screened for HIV before enrollment. Only 1 participant was HIV positive. However, the participant with HIV came off study before post treatment was collected so change cannot be assessed. As pre-specified in the protocol, participants are taken off study for disease progression.
Secondary
Duration of Overall Response (DOR)
Duration of overall response is measured from the time measurement criteria are met for Complete Response until the first date that recurrent or progressive disease is objectively document. Complete Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Complete Response is disappearance of all target lesions.
Time frame: 12 months of follow up, approximately 14 months
Population: This outcome measure was not measurable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MTS-01 Grade 1 | Duration of Overall Response (DOR) | NA months |
Secondary
Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment
RTOG grade 1-5 were used to assess skin toxicity in the groin (right and left inguinal area) and gluteal cleft, as well as two control sites. Grade 0 is no skin toxicity, Grade 1 is follicular, faint or dull erythema, Grade 3 is tender or bright erythema, Grade 3 is confluent, moist desquamation, Grade 4 is ulceration, hemorrhage, or necrosis, and Grade 5 is death due to radiation toxicity.
Time frame: baseline, weeks 1-6, follow up at 1 week, follow up at 2 weeks, and follow up at 4 weeks
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 2 weeks | 1.2 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 4 | 0.6 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 6 | 1.2 Grade | Standard Deviation 1.1 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 1 | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 1 week | 1.8 Grade | Standard Deviation 0.8 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 4 weeks | 0.4 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Baseline | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 5 | 1 Grade | Standard Deviation 0.7 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 2 | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 1 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 3 | 0.4 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 2 | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 4 | 0.6 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 3 | 0.2 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 2 weeks | 1 Grade | Standard Deviation 0 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 1 week | 1 Grade | Standard Deviation 0 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Baseline | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 6 | 1.2 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 1 | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 5 | 0.8 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 4 weeks | 0.2 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 3 | 0.2 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 4 weeks | 0.2 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Baseline | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 1 | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 2 | 0 Grade | Standard Deviation 0 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 2 weeks | 1 Grade | Standard Deviation 0 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 4 | 0.6 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 5 | 0.8 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 6 | 1.2 Grade | Standard Deviation 0.5 |
| MTS-01 Grade 3 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 1 week | 1 Grade | Standard Deviation 0 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 1 week | 0.6 Grade | Standard Deviation 0.5 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 4 | 0.2 Grade | Standard Deviation 0.5 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 1 | 0 Grade | Standard Deviation 0 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 5 | 0.2 Grade | Standard Deviation 0.5 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Baseline | 0 Grade | Standard Deviation 0 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 6 | 0.4 Grade | Standard Deviation 0.5 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 4 weeks | 0.6 Grade | Standard Deviation 0 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 2 weeks | 0.8 Grade | Standard Deviation 0.5 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 3 | 0.2 Grade | Standard Deviation 0.5 |
| 5FU/MMC/IMRT Grade 2 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 2 | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 2 weeks | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 3 | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 4 | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 1 | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 6 | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 1 week | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Follow up at 4 weeks | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 5 | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Baseline | 0 Grade | Standard Deviation 0 |
| 5-FU/MMC/IMRT Grade 3-4 | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | Week 2 | 0 Grade | Standard Deviation 0 |
Secondary
Mean Percentage Pain Relief After Medication
The Brief Pain Inventory Scale questionnaire were used to assess pain relief after medication. Participants rated pain relief on a scale of 0% (no relief) to 100% (complete relief) and a mean and full range were reported.
Time frame: Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Mean Percentage Pain Relief After Medication | Baseline | 90.0 percentage pain relief |
| MTS-01 Grade 1 | Mean Percentage Pain Relief After Medication | Treatment week 3 | 93.8 percentage pain relief |
| MTS-01 Grade 1 | Mean Percentage Pain Relief After Medication | Treatment week 6 | 44.0 percentage pain relief |
| MTS-01 Grade 1 | Mean Percentage Pain Relief After Medication | 1 month follow up | 89.0 percentage pain relief |
| MTS-01 Grade 1 | Mean Percentage Pain Relief After Medication | 3 months follow up | 83.0 percentage pain relief |
Secondary
Number of Cluster of Differentiation 4+ (CD4) Cells Per Gram of Biopsied Intestinal Tissue
Number of Cluster of Differentiation 4+ (CD4) cells per gram of biopsied intestinal tissue. The number of CD4 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue.
Time frame: Baseline and 1 year follow up
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Number of Cluster of Differentiation 4+ (CD4) Cells Per Gram of Biopsied Intestinal Tissue | Baseline | 17.64 CD4+cells/gm tissue(x 10^5) |
| MTS-01 Grade 1 | Number of Cluster of Differentiation 4+ (CD4) Cells Per Gram of Biopsied Intestinal Tissue | 1 year follow up | 12.72 CD4+cells/gm tissue(x 10^5) |
Secondary
Number of Cluster of Differentiation 8+ (CD8) Cells Per Gram of Biopsied Intestinal Tissue
Number of Cluster of differentiation 8+ (CD8) cells per gram of biopsied intestinal tissue. The number of CD8 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue.
Time frame: Baseline and 1 year follow up
Population: 1/6 participants enrolled withdrew before treatment. 3 participants underwent optional biopsy.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Number of Cluster of Differentiation 8+ (CD8) Cells Per Gram of Biopsied Intestinal Tissue | Baseline | 4.8 CD8+cells/gm tissue(x 10^5) |
| MTS-01 Grade 1 | Number of Cluster of Differentiation 8+ (CD8) Cells Per Gram of Biopsied Intestinal Tissue | 1 year follow up | 4.0 CD8+cells/gm tissue(x 10^5) |
Secondary
Number of Participants That Required a Treatment Break Relative to Hematologic Toxicity (Non-dermatologic)
Number of participants that required a treatment break relative to hematologic (e.g. thrombocytopenia, leukopenia) toxicity (non-dermatologic).
Time frame: From beginning until completion of radiation treatment up to 46 days
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MTS-01 Grade 1 | Number of Participants That Required a Treatment Break Relative to Hematologic Toxicity (Non-dermatologic) | 0 Participants |
Secondary
Number of Participants Treated With Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) That Required Opiates
Opiates are strong drugs prescribed by prescription used for maximum pain relief.
Time frame: Completion of study, approximately 14 months after start of treatment
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MTS-01 Grade 1 | Number of Participants Treated With Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) That Required Opiates | 5 Participants |
Secondary
Number of Participants With 12 Month Disease Free Survival (DFS) Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT)
DFS is defined as the duration of time from start of treatment to time of progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions.
Time frame: 12 months
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MTS-01 Grade 1 | Number of Participants With 12 Month Disease Free Survival (DFS) Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 4 Participants |
Secondary
Number of Participants With 12-month Progression-free Survival Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions.
Time frame: 12 months
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MTS-01 Grade 1 | Number of Participants With 12-month Progression-free Survival Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 4 Participants |
Secondary
Number of Participants With Human Immunodeficiency Virus (HIV) in Biopsy Tissue From Rectal Mucosa
Optional snag biopsies pre and post were collected from participants rectal mucosa to enumerate cell counts.
Time frame: Baseline and Course 1 Day 28
Population: This outcome measure could not be completed. 1/6 participants enrolled withdrew before treatment. No participants with HIV ribonucleic acid (RNA) underwent optional biopsy. HIV RNA is not analyzed unless a patient has HIV. Thus, data not collected.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Number of Participants With Human Immunodeficiency Virus (HIV) in Biopsy Tissue From Rectal Mucosa | Baseline | — |
| Unknown | Number of Participants With Human Immunodeficiency Virus (HIV) in Biopsy Tissue From Rectal Mucosa | Course 1 Day 28 | — |
Secondary
Number of Participants With Tumor Tissue Negative for Human Papilloma Virus (HPV)
HPV is a sexually transmitted infection that can cause warts and cervical cancer. HPV test detects deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) of HPV in a cell sample (i.e. cervical).
Time frame: Pretreatment
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MTS-01 Grade 1 | Number of Participants With Tumor Tissue Negative for Human Papilloma Virus (HPV) | 5 Participants |
Secondary
Overall Survival
OS is defined as the duration of time from start of treatment to time of death.
Time frame: start of treatment to time of death, approximately 14 months
Population: This outcome measure could not be completed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MTS-01 Grade 1 | Overall Survival | NA months |
Secondary
Pain Interference
The Brief Pain Inventory Scale questionnaire were used to assess pain interference. Participants rated pain interference on a scale of 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Pain Interference | Pain interference at baseline | 1.73 Scores on a scale |
| MTS-01 Grade 1 | Pain Interference | Pain interference at treatment week 3 | 3.00 Scores on a scale |
| MTS-01 Grade 1 | Pain Interference | Pain interference at treatment week 6 | 6.70 Scores on a scale |
| MTS-01 Grade 1 | Pain Interference | Pain interference at 1 month follow up | 3.17 Scores on a scale |
| MTS-01 Grade 1 | Pain Interference | Pain interference at 3 months follow up | 1.87 Scores on a scale |
Secondary
Percentage of Total Viable Cells That Were Cluster of Differentiation 3+ (CD3+) Cells in Biopsied Tissue
Percentage of total viable cells that were Cluster of differentiation 3+ (CD3+) cells in biopsied tissue.
Time frame: Baseline and 1 year
Population: 1/6 participants enrolled withdrew before treatment. 3 participants underwent optional biopsy.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Percentage of Total Viable Cells That Were Cluster of Differentiation 3+ (CD3+) Cells in Biopsied Tissue | Baseline | 7.93 percentage of cells |
| MTS-01 Grade 1 | Percentage of Total Viable Cells That Were Cluster of Differentiation 3+ (CD3+) Cells in Biopsied Tissue | 1 year | 4.40 percentage of cells |
Secondary
Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28
Peripheral blood mononuclear cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor beta-1 (TGF-beta1) were sampled from peripheral blood from rectal associated lymphoid tissue to evaluate immune cell subsets at baseline and after treatment with MTS-0 and 15-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT). It is unknown if a lower or higher numbers has prognostic significance.
Time frame: Baseline and Course 1 Day 28
Population: 1/6 participants enrolled withdrew before treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | VEGF at baseline | 151.24 pg/ml | Standard Deviation 45 |
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | VEGF at Course 1 Day 28 | 127.26 pg/ml | Standard Deviation 63.6 |
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | TNF-alpha at baseline | 3.36 pg/ml | Standard Deviation 1.2 |
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | TNF-alpha at Course 1 Day 28 | 3.21 pg/ml | Standard Deviation 2.5 |
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | IL-7 at baseline | 11.32 pg/ml | Standard Deviation 6.2 |
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | IL-7 at Course 1 Day 28 | 15.62 pg/ml | Standard Deviation 10.3 |
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | TGF-beta 1 at baseline | 14435 pg/ml | Standard Deviation 3711.7 |
| MTS-01 Grade 1 | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | TGF-beta 1 at Course 1 Day 28 | 7946 pg/ml | Standard Deviation 2729.3 |
Secondary
Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment
Ratio of the number Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) cells in the circulation and tissue pre and post treatment. The number of cells of CD4 are divided by the number of cells of CD8.
Time frame: Pre-treatment and post treatment tissue (CD4), and pre-treatment and post treatment circulation (CD8)
Population: 3/6 participants were analyzed because 1 participant was enrolled but withdrew before treatment, samples were collected at the time of optional biopsy which was conducted in 3 patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MTS-01 Grade 1 | Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | CD4:CD8 Pre-treatment tissue | 5.2 Ratio of CD4:CD8 cells |
| MTS-01 Grade 1 | Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | CD4:CD8 post treatment tissue | 1.89 Ratio of CD4:CD8 cells |
| MTS-01 Grade 1 | Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | CD4:CD8 pre-treatment circulation | 2.95 Ratio of CD4:CD8 cells |
| MTS-01 Grade 1 | Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | CD4:CD8 post treatment circulation | 1.56 Ratio of CD4:CD8 cells |