Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer
Virginia Commonwealth University
Summary
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Description
This trial involves 4 cycles of systemic chemotherapy followed by short-course RT with concurrent 5-FU neoadjuvant chemoradiotherapy (CRT) and subsequent consolidation with 4 cycles of systemic chemotherapy prior to surgery or, for those who achieve cCR, the option of non-operative active surveillance.Three-year disease free survival (DFS) defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response (cCR) or date of total mesorectal excision (TME) at surgery (whichever is earlier).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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-e…
Interventions
- DrugChemotherapy
Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)
- RadiationRadiation Therapy
Pelvic Intensity-modulated radiation therapy (IMRT)
Locations (3)
- Virginia Cancer InstituteRichmond, Virginia
- Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia
- VCU Community Memorial HealthcenterSouth Hill, Virginia