Anus Neoplasms
Conditions
Keywords
Anal Cancer
Brief summary
The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.
Interventions
RADIATIONProton therapy
Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
DRUGChemotherapy
5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
Sponsors
Jordan Kharofa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Karnofsky Performance Status \>70% * Histologically documented squamous or basaloid carcinoma of the anal canal * Stage T2-4 disease with any N category
Exclusion criteria
• Patients with a life expectancy of \< 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Acute Toxicity | 3 months | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | at 6 months from the completion of chemoradiation | Complete response was clinically determined by digital rectal examination and proctosigmoidoscopy supplemented with pelvic axial imaging. Biopsy was not required. The complete response was the absence of disease based on these evaluations. Any measurable disease at 6 months from the completion of chemoradiation will be considered a local treatment failure. Any tumor recurrence in the anus in patients who initially had a complete response will be considered a local recurrence. |
| Local Progression Free Survival | every 6 months up to 60 months | This is the percentage of subjects that were free of local progression. |
| Rates of Late Toxicity | every 6 months up to 60 months | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity |
| Distant Metastases Free Survival | every 6 months up to 60 months | This is the percentage of subjects that were free of distant metastases. |
| Quality of Life Changes | before treatment and 12 months after start of treatment | Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months. This measure used the difference total score for each subject's baseline and latest PROCTCAE available. The reported statistic is the number of subjects that showed a reduction in scores between the two time points. |
| Overall Survival | every 6 months up to 24 months | This is an estimated percentage of participants that is alive at 2 years. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proton Therapy and Chemotherapy Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
Proton therapy: Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
Chemotherapy: 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Proton Therapy and Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 10 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 14 |
| other Total, other adverse events | 13 / 14 |
| serious Total, serious adverse events | 7 / 14 |
Outcome results
Primary
Rates of Acute Toxicity
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Time frame: 3 months
Population: The population is the subjects that had at least one adverse event that was grade 3 or higher in one of the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity | Rates of Acute Toxicity | 12 Participants |
Secondary
Complete Response Rate
Complete response was clinically determined by digital rectal examination and proctosigmoidoscopy supplemented with pelvic axial imaging. Biopsy was not required. The complete response was the absence of disease based on these evaluations. Any measurable disease at 6 months from the completion of chemoradiation will be considered a local treatment failure. Any tumor recurrence in the anus in patients who initially had a complete response will be considered a local recurrence.
Time frame: at 6 months from the completion of chemoradiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity | Complete Response Rate | 11 Participants |
Secondary
Distant Metastases Free Survival
This is the percentage of subjects that were free of distant metastases.
Time frame: every 6 months up to 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity | Distant Metastases Free Survival | 13 Participants |
Secondary
Local Progression Free Survival
This is the percentage of subjects that were free of local progression.
Time frame: every 6 months up to 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity | Local Progression Free Survival | 12 Participants |
Secondary
Overall Survival
This is an estimated percentage of participants that is alive at 2 years.
Time frame: every 6 months up to 24 months
Population: time from the date of registration to the date of death due to all causes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity | Overall Survival | 76 percentage of subjects |
Secondary
Quality of Life Changes
Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months. This measure used the difference total score for each subject's baseline and latest PROCTCAE available. The reported statistic is the number of subjects that showed a reduction in scores between the two time points.
Time frame: before treatment and 12 months after start of treatment
Population: This measure examines all 14 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity | Quality of Life Changes | 9 Participants |
Secondary
Rates of Late Toxicity
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Time frame: every 6 months up to 60 months
Population: The population is the subjects that had at least one adverse event that was grade 3 or higher in one of the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity | Rates of Late Toxicity | 6 Participants |