MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
Trial Parameters
Brief Summary
This study is a prospective, open-label, phase I design.
Eligibility Criteria
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 Oncology Group (ECOG) status 0-2 within 45 days of study entry. 6. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment. 7. MR of the rectum is mandatory for staging and follow-up. 8. Chest CT scan within 45 days prior to study entry. 9. Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (