NCT04643366 Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
| NCT ID | NCT04643366 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Virginia Commonwealth University |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2021-01-28 |
| Primary Completion | 2028-01-31 |
Trial Parameters
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Brief Summary
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Eligibility Criteria
Inclusion Criteria: * Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy * Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup: * Colonoscopy, unless patient presents with an obstructing lesion * Within 30 days prior to registration: * History/physical examination * Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis or whole-body PET-CT or MRI * Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging Note: Patients may have initiated standard mFOLFOX6 treatment before study registration provided that they met the above criteria before initiating treatment and can feasibly continue to CRT according to the timeline described in Section * ECOG Performance Stat
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