MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
ConditionRectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
This study is a prospective, open-label, phase I design.
Eligibility criteria
Qualifiers
Age ≥ 18.
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.
Disqualifiers
Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease.
Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion.
Trial design
Treatments tested in this trial
- Capecitabine
- Initial Dose of Radiation before Dose Escalation
- Cohort A: Dose Escalation Radiation
- Cohort B: Dose Escalation Radiation
- Cohort C: Dose Escalation Radiation
- FOLFOX
Treatment groups
22 Participants
are divided into 3 treatment groupsLocations
1Froedtert & the Medical College of Wisconsin53226, MilwaukeeWisconsin, United States
Sponsors and collaborators
Medical College of Wisconsin
Lead sponsor
Source ClinicalTrials.gov