MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
Medical College of Wisconsin
Summary
This study is a prospective, open-label, phase I design.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18. 2. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum. 3. Determined on staging evaluation to be clinical stage I, II or III. 4. No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise. 5. Eastern Cooperative Oncol…
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
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin