Pancreatic Neoplasms
Conditions
Keywords
stereotactic radiotherapy, pancreatic adenocarcinoma
Brief summary
This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies. Primary Objective • To estimate rates of acute (within 3 months of treatment) grade 3 or greater gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers who have previously received other treatment. Secondary Objectives * To estimate rates of late (\> 3 months after treatment) grade 2 gastritis, enteritis, fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers * To estimate rates of local progression, overall survival, metastasis-free survival, and progression-free survival in patients with pancreatic or periampullary cancers treated with fractionated Linac-based SBRT. * To evaluate the ability of Linac-based SBRT to provide pain control in patients with pain related to a pancreatic or periampullary tumor. * To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for pancreatic or periampullary cancers.
Detailed description
Patients will receive 5 fractions of 5 gray (Gy) or 6.6 Gy delivered over a five-day period based on whether or not they have received prior radiation therapy to the pancreatic region. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week. Initial patient positioning will be based on volumetric kV (cone-beam computerized tomography) imaging with shifts to bony anatomy as appropriate. Orthogonal kV/MV or kV/kV projection imaging will be used to verify the location of the fiducials prior to delivery of the first treatment beam. A secondary shift based on the location of fiducials may be utilized, as indicated by the position of the fiducials. For free-breathing treatments, kV fluoroscopic images should be obtained to confirm the anticipated position of these fiducials during the entire respiratory cycle. Active monitoring of treatment delivery accuracy will be accomplished using kV and/or MV projection imaging, either immediately before or during all (or a subset of) treatment fields. Patient-specific dosimetric quality assurance (QA) will be performed as per standard practice in the Department of Radiation Oncology, Indiana University School of Medicine.
Interventions
RADIATIONStereotactic Body Radiation
Sponsors
Indiana University
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
* Age \>18 years. * Karnofsky Performance Status \>70% * Histologically confirmed adenocarcinoma of the pancreas or ampulla of Vater; at least the majority of the histopathologic specimen must be identified as adenocarcinoma as opposed to another histologic subtype. In patients with a diagnosis of recurrent disease (based on radiographic progression and/or rising CA19-9 levels) and a history of a biopsy-proven adenocarcinoma of the pancreas or the ampulla of Vater, repeat biopsy of the recurrence site is not required for participation of the trial. * Pancreatic or periampullary tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning. * Patients who have been treated with any combination of surgical resection and neoadjuvant/adjuvant conventional chemoradiation therapy for resectable disease or conventional chemoradiation as definitive treatment for unresectable or borderline resectable disease are eligible for the study, provided that at least 180 days have elapsed since completing any previous radiation treatment. Patients who have been receiving continued chemotherapy following their initial radiation treatment are eligible regardless of when the most recent chemotherapy was received. Those patients who have received prior radiation therapy will constitute Cohort A and will receive stereotactic body radiation (SBRT) as 5 gray (Gy) x 5. * Patients who have not previously undergone radiation therapy can have a history of treatment with either chemotherapy (for unresectable/borderline resectable disease) or any combination of surgery and chemotherapy (for resectable disease). Patients with no history of prior radiation treatment will constitute Cohort B and will receive SBRT as 6.6 Gy x 5. Please note that patients must have received at least two cycles of chemotherapy (with selection of drugs at the discretion of the treating oncologist) before SBRT treatment on protocol. * Acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy): * Leukocytes \>3,000/μL * Absolute neutrophil count \>1,500μL * Platelets \>100,000/μL * Total Bilirubin ≤1.5x institutional upper limit of normal * Aspartate transaminase (AST(SGOT))/Alanine transaminase (ALT(SGPT)) \<2.5x institutional upper limit of normal * Creatinine ≤ institutional upper limit of normal OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * Ability to understand and the willingness to sign a written informed consent document. * Life expectancy \> 3 months. * Radio-opaque markers must be present within the tumor bed. In patients who have undergone surgical resection, radio-opaque surgical clips within the tumor bed can be used as fiducials. Patients without surgical clips in the tumor bed must be able to have fiducials placed endoscopically, laparoscopically, or through a CT- or ultrasound-guided technique. If not, the tumor must be posterior and adjacent to the aorta, and treatment will only be permitted at the discretion of the Principal Investigator.
Exclusion criteria
* Age \< 18 years. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix. Patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for \> 5 years will be allowed to enter the trial. * Pregnant and breastfeeding women are excluded as are women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test. * Patients with a life expectancy of \< 3 months. * Patients with metastatic disease. * Patients with evidence of gross tumor invasion into the lumen of the stomach or small bowel are not eligible; if imaging suggests luminal invasion of tumor, this must be ruled out endoscopically before the patient can be enrolled on study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Up to 90 days after treatment | Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 1 year after treatment | This measure reports the overall survival probability from the Kaplan Meier method. The survival time was calculated from the date of treatment start to the date of death and patients who did not expire were censored at their last date known alive. |
| Progression-Free Survival | 1 year after treatment | This measure represents the progression-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of progression or death. Patients who did not experience progression were censored at their last known date alive. |
| Metastasis-Free Survival | 1 year after treatment | This represents the metastasis-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of metastasis or death. Patients who did not experience metastasis or death were censored at their last known date alive. |
| Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | 90 or more days after treatment, up to 7 years | Measures include the percentage of patients who experienced the toxicity with a grade of 2 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0. |
| Quality of Life Scores - Global Health Status / Quality of Life | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Global Health Status / Quality of Life composite score was calculated by combining the scores for questions 29 and 30 and calculating Score = {(RS -1) range}×100. Responses for questions 29 and 30 ranged from 1 to 7 with 1 indicating Very Poor and 7 indicating Excellent. Higher scores indicate a better quality of life with a minimum composite score of 0 and a maximum composite score of 100. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite after treatment score. |
| Quality of Life Scores - Functional Scales | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Functional scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {1 - ((RS -1) / range)}×100. The response options for each question were 1-Not at all, 2-A little, 3-Quite a bit, and 4-Very Much. Higher scores indicate a high/healthy level of functioning with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite after treatment score. |
| Quality of Life Scores - Symptom Scales | Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment) | Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Symptom scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {(RS -1) range}×100. The response options for each question were 1-Not at all, 2-A little, 3-Quite a bit, and 4-Very Much. Higher scores indicate a high level of symptomatology / problems with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite after treatment score. |
| Wong-Baker FACES Pain Rating Score | Baseline (before treatment), Week 1 (during treatment), Week 2 (during treatment), Month 1 (after treatment), and Month 3 (after treatment) | Measured with the Wong-Baker FACES 0-10 scale where higher scores indicate more pain. Patients self-reported the score before (baseline), during (weeks 1 and 2), and after (1 and 3 months) treatment. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1 and 3) were averaged to create a composite after treatment score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. | 3 |
| Cohort B Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5 | 33 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease Progression | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort A | Total | Cohort B |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 7.2 | 66.3 years STANDARD_DEVIATION 9.3 | 66.5 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 33 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 30 Participants | 27 Participants |
| Region of Enrollment United States | 3 Participants | 36 Participants | 33 Participants |
| Sex: Female, Male Female | 2 Participants | 20 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 16 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 33 / 33 |
| other Total, other adverse events | 3 / 3 | 24 / 33 |
| serious Total, serious adverse events | 3 / 3 | 33 / 33 |
Outcome results
Primary
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Time frame: Up to 90 days after treatment
Population: Includes all patients in cohorts A and B who met eligibility criteria for primary outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Hematologic: Lymphocyte Count Decreased | 13.89 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Hematologic: White Blood Cell Decreased | 0.00 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Gastrointestinal: Nausea | 2.78 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Gastrointestinal: Abdominal Pain | 0.00 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Gastrointestinal: Diarrhea | 0.00 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Gastrointestinal: Bloating | 0.00 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Gastrointestinal: Flatulence | 0.00 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Gastrointestinal: Gastritis | 0.00 percentage of participants |
| All Eligible Participants | Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage) | Gastrointestinal: Vomiting | 2.78 percentage of participants |
Secondary
Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)
Measures include the percentage of patients who experienced the toxicity with a grade of 2 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Time frame: 90 or more days after treatment, up to 7 years
Population: Includes those patients who were determined to be eligible for the secondary outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Eligible Participants | Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Gastritis | 0.00 percentage of participants |
| All Eligible Participants | Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Enteritis | 0.00 percentage of participants |
| All Eligible Participants | Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Fistula | 0.00 percentage of participants |
| All Eligible Participants | Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Ulcer | 0.00 percentage of participants |
| All Eligible Participants | Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Diarrhea | 0.00 percentage of participants |
| All Eligible Participants | Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage) | Vomiting | 0.00 percentage of participants |
Secondary
Metastasis-Free Survival
This represents the metastasis-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of metastasis or death. Patients who did not experience metastasis or death were censored at their last known date alive.
Time frame: 1 year after treatment
Population: Includes patients in Cohort B who were determined to be eligible for the secondary outcomes analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort B | Metastasis-Free Survival | .4846 survival probability |
Secondary
Overall Survival
This measure reports the overall survival probability from the Kaplan Meier method. The survival time was calculated from the date of treatment start to the date of death and patients who did not expire were censored at their last date known alive.
Time frame: 1 year after treatment
Population: Includes patients in Cohort B who were considered eligible for the outcome analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort B | Overall Survival | .4849 survival probability |
Secondary
Progression-Free Survival
This measure represents the progression-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of progression or death. Patients who did not experience progression were censored at their last known date alive.
Time frame: 1 year after treatment
Population: Includes patients in cohort B who were determined to be eligible for the secondary objectives.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort B | Progression-Free Survival | .3939 survival probability |
Secondary
Quality of Life Scores - Functional Scales
Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Functional scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {1 - ((RS -1) / range)}×100. The response options for each question were 1-Not at all, 2-A little, 3-Quite a bit, and 4-Very Much. Higher scores indicate a high/healthy level of functioning with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite after treatment score.
Time frame: Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment)
Population: Includes patients who were eligible for the secondary outcomes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Eligible Participants | Quality of Life Scores - Functional Scales | Role Functioning - During Treatment | 75.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Emotional Functioning - After Treatment | 75.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Physical Functioning - During Treatment | 86.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Cognitive Functioning - Before Treatment | 91.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Role Functioning - After Treatment | 75.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Cognitive Functioning - During Treatment | 100.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Role Functioning - Before Treatment | 50.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Cognitive Functioning - After Treatment | 83.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Emotional Functioning - Before Treatment | 75.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Social Functioning - Before Treatment | 33.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Physical Functioning - After Treatment | 80.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Social Functioning - During Treatment | 83.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Emotional Functioning - During Treatment | 83.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Social Functioning - After Treatment | 66.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Functional Scales | Physical Functioning - Before Treatment | 76.67 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Social Functioning - After Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Physical Functioning - Before Treatment | 93.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Physical Functioning - During Treatment | 86.67 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Physical Functioning - After Treatment | 86.67 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Role Functioning - Before Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Role Functioning - During Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Role Functioning - After Treatment | 100.00 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Emotional Functioning - Before Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Emotional Functioning - During Treatment | 91.67 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Emotional Functioning - After Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Cognitive Functioning - Before Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Cognitive Functioning - During Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Cognitive Functioning - After Treatment | 83.33 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Social Functioning - Before Treatment | 66.67 score on a scale |
| Cohort B | Quality of Life Scores - Functional Scales | Social Functioning - During Treatment | 66.67 score on a scale |
Comparison: The null hypothesis was that there was no difference in composite physical functioning composite scores across treatment phase.p-value: 0.179Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite role functioning composite scores across treatment phase.p-value: 0.789Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite emotional functioning composite scores across treatment phase.p-value: 0.303Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite cognitive functioning composite scores across treatment phase.p-value: 0.989Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite social functioning composite scores across treatment phase.p-value: 0.436Regression, Logistic
Secondary
Quality of Life Scores - Global Health Status / Quality of Life
Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Global Health Status / Quality of Life composite score was calculated by combining the scores for questions 29 and 30 and calculating Score = {(RS -1) range}×100. Responses for questions 29 and 30 ranged from 1 to 7 with 1 indicating Very Poor and 7 indicating Excellent. Higher scores indicate a better quality of life with a minimum composite score of 0 and a maximum composite score of 100. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite after treatment score.
Time frame: Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment)
Population: Includes patients who were eligible for the secondary outcomes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Eligible Participants | Quality of Life Scores - Global Health Status / Quality of Life | Global Health Status - Before Treatment | 83.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Global Health Status / Quality of Life | Global Health Status - During Treatment | 83.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Global Health Status / Quality of Life | Global Health Status - After Treatment | 79.17 score on a scale |
| Cohort B | Quality of Life Scores - Global Health Status / Quality of Life | Global Health Status - Before Treatment | 75.00 score on a scale |
| Cohort B | Quality of Life Scores - Global Health Status / Quality of Life | Global Health Status - During Treatment | 66.67 score on a scale |
| Cohort B | Quality of Life Scores - Global Health Status / Quality of Life | Global Health Status - After Treatment | 70.83 score on a scale |
Comparison: The null hypothesis was that there was no difference in composite global health status / quality of life scores across treatment phase.p-value: 0.27Regression, Logistic
Secondary
Quality of Life Scores - Symptom Scales
Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Symptom scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {(RS -1) range}×100. The response options for each question were 1-Not at all, 2-A little, 3-Quite a bit, and 4-Very Much. Higher scores indicate a high level of symptomatology / problems with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite after treatment score.
Time frame: Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment)
Population: Includes patients who were eligible for the secondary outcomes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Pain - During Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Insomnia - After Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Nausea and Vomiting - During Treatment | 8.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Appetite Loss - Before Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Pain - After Treatment | 33.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Appetite Loss - During Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Fatigue - During Treatment | 33.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Appetite Loss - After Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Dyspnea - Before Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Constipation - Before Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Nausea and Vomiting - After Treatment | 25.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Constipation - During Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Dyspnea - During Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Constipation - After Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Nausea and Vomiting - Before Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Diarrhea - Before Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Dyspnea - After Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Diarrhea - During Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Pain - Before Treatment | 41.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Diarrhea - After Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Insomnia - Before Treatment | 33.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Financial Difficulties - Before Treatment | 66.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Fatigue - After Treatment | 44.44 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Financial Difficulties - During Treatment | 16.67 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Insomnia - During Treatment | 0.00 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Financial Difficulties - After Treatment | 33.33 score on a scale |
| All Eligible Participants | Quality of Life Scores - Symptom Scales | Fatigue - Before Treatment | 44.44 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Financial Difficulties - After Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Fatigue - Before Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Fatigue - During Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Fatigue - After Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Nausea and Vomiting - Before Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Nausea and Vomiting - During Treatment | 16.67 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Nausea and Vomiting - After Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Pain - Before Treatment | 16.67 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Pain - During Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Pain - After Treatment | 16.67 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Dyspnea - Before Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Dyspnea - During Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Dyspnea - After Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Insomnia - Before Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Insomnia - During Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Insomnia - After Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Appetite Loss - Before Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Appetite Loss - During Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Appetite Loss - After Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Constipation - Before Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Constipation - During Treatment | 16.67 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Constipation - After Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Diarrhea - Before Treatment | 16.67 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Diarrhea - During Treatment | 0.00 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Diarrhea - After Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Financial Difficulties - Before Treatment | 33.33 score on a scale |
| Cohort B | Quality of Life Scores - Symptom Scales | Financial Difficulties - During Treatment | 33.33 score on a scale |
Comparison: The null hypothesis was that there was no difference in composite fatigue symptom scores across treatment phase.p-value: 0.659Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite nausea and vomiting symptom scores across treatment phase.p-value: 0.295Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite pain symptom scores across treatment phase.p-value: 0.299Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite dyspnea symptom scores across treatment phase.p-value: 0.794Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite insomnia symptom scores across treatment phase.p-value: 0.45Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite appetite loss symptom scores across treatment phase.p-value: 0.389Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite constipation symptom scores across treatment phase.p-value: 0.011Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite diarrhea symptom scores across treatment phase.p-value: 0.101Regression, Logistic
Comparison: The null hypothesis was that there was no difference in composite financial difficulty symptom scores across treatment phase.p-value: 0.306Regression, Logistic
Secondary
Wong-Baker FACES Pain Rating Score
Measured with the Wong-Baker FACES 0-10 scale where higher scores indicate more pain. Patients self-reported the score before (baseline), during (weeks 1 and 2), and after (1 and 3 months) treatment. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite during treatment score. Similarly, scores collected after treatment (months 1 and 3) were averaged to create a composite after treatment score.
Time frame: Baseline (before treatment), Week 1 (during treatment), Week 2 (during treatment), Month 1 (after treatment), and Month 3 (after treatment)
Population: Includes all patients who were determined to be eligible for the secondary outcomes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Eligible Participants | Wong-Baker FACES Pain Rating Score | Before Treatment Score | 1.00 score on a scale |
| All Eligible Participants | Wong-Baker FACES Pain Rating Score | During Treatment Score | 2.00 score on a scale |
| All Eligible Participants | Wong-Baker FACES Pain Rating Score | After Treatment Score | 2.00 score on a scale |
| Cohort B | Wong-Baker FACES Pain Rating Score | After Treatment Score | 0.00 score on a scale |
| Cohort B | Wong-Baker FACES Pain Rating Score | Before Treatment Score | 2.00 score on a scale |
| Cohort B | Wong-Baker FACES Pain Rating Score | During Treatment Score | 0.00 score on a scale |
Comparison: For Cohort B, pain scores were compared across treatment phase (before, during, and after) using ordinal logistic regression models with repeated measures.p-value: 0.824Mixed Models Analysis