MRI-Guided Adaptive Radiation Dose Escalation

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.)

Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.

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.

This study is a prospective, open-label, phase I design.

Live record on ClinicalTrials.gov →

• Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.
• Determined on staging evaluation to be clinical stage I, II or III.
• 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.
• Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.
• History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment.
• MR of the rectum is mandatory for staging and follow-up.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.