MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
Summary
This study is a prospective, open-label, phase I design.
Detailed description
Study Rationale: There are limited studies evaluating real-time adaptive radiation therapy for locally advanced (Stage I-III) rectal adenocarcinoma with the goal of accomplishing organ preservation. We are testing higher doses of radiation therapy, using a novel method of real-time adaptive MRI-based radiation therapy treatment. Hypothesis: We hypothesize that adaptive magnetic resonance (MR) -guided radiation therapy will result in acceptable toxicity and that a maximum-tolerated dose can be determined in a phase I setting. Intervention Description: The intervention in this circumstance is higher doses of radiation therapy focused within the tumor given using adaptive MR guidance. Radiation Doses being applied in this study: Cohort A- 64 Gy over 32 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to total dose of 64 Gy over 32 total fractions. Cohort B- 68 Gy over approximately 34 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 68 Gy over 34 total fractions. Cohort C- 72 Gy over 36 total fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 72 Gy over 36 total fractions. Dose-Limiting Toxicity from Radiation Therapy: A dose-limiting toxicity (DLT) as per NCI CTCAE version 5. Specifically, this encompasses the need for additional treatments including the following: transfusion, invasive intervention, or hospitalization indicated. The presence of such a DLT would result in the halting of radiation therapy and impact on the dose levels of radiation therapy applied in the trial.
Arms & interventions
- DrugCapecitabine
825 mg/m\^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C.
- DeviceInitial Dose of Radiation before Dose Escalation
50 Gy over 25 frac.
- DeviceCohort A: Dose Escalation Radiation
Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.
- DeviceCohort B: Dose Escalation Radiation
Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.
- DeviceCohort C: Dose Escalation Radiation
Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.
- DrugFOLFOX
After the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.)
Outcome measures
Primary
The number of subjects in Cohort A with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Time frame: Up to 11.5-week period
The number of subjects in Cohort B with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Time frame: Up to 11.5-week period
The number of subjects in Cohort C with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Time frame: Up to a 12.1-week period.
Secondary
The number of subjects in Cohort A with a complete clinical response (CCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort B with a complete clinical response (CCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort C with a complete clinical response (CCR) to treatment.
Time frame: 32.1 weeks
The number of subjects in Cohort A with a noncomplete response (NCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort B with a noncomplete response (NCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort C with a noncomplete response (NCR) to treatment.
Time frame: 32.1 weeks
Circulating tumor deoxyribonucleic acid (ctDNA)
Time frame: Baseline, 12.1 weeks, 32 weeks, one year and two years.
The number of subjects with dose-limiting toxicities in Cohort A.
Time frame: 11.5-week period
The number of subjects with dose-limiting toxicities in Cohort B.
Time frame: 11.5-week period
The number of subjects with dose-limiting toxicities in Cohort C.
Time frame: 12.1- week period
Change from baseline in the EQ-5D-SL quality of life questionnaire
Time frame: Baseline and up to 12.1 weeks.
Change from baseline in the Memorial Sloan Kettering Bowel Function Index (MSKCC BFI) Score
Time frame: Baseline and up to 12.1 weeks.
Change from baseline in the Wexner Fecal Incontinence Score
Time frame: Baseline and up to 12.1 weeks.
Eligibility criteria
Study locations (1)
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226