Actively Recruiting
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
Led by Virginia Commonwealth University · Updated on 2026-01-27
54
Participants Needed
3
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
CONDITIONS
Official Title
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologic diagnosis of adenocarcinoma of the rectum within 90 days prior to registration, with tumor located below the peritoneal reflection or within 12 cm of the anal verge on flexible endoscopy
- Clinically staged T3-4 N0 M0 or T any N1-2 M0 based on colonoscopy (unless obstructed), imaging to exclude distant metastases, and pelvic MRI or transrectal ultrasound for T staging
- ECOG Performance Status of 2 or less
- Age 18 years or older
- Adequate bone marrow function: ANC ≥ 1,200 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 8.0 g/dL (transfusions allowed)
- Adequate liver and kidney function: AST and alkaline phosphatase < 2.5 x ULN, bilirubin ≤ 2.5 ULN, creatinine clearance > 30 mL/min
- Candidate for curative surgical resection
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to chemotherapy start
- Women of childbearing potential and men must agree to use medically accepted birth control during treatment and for 3 months after chemotherapy
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Prior radiation therapy overlapping with planned study treatment
- Clinically significant cardiac disease precluding systemic therapy with chemotherapy agents
- Serious uncontrolled infection (grade 3 or higher)
- Pulmonary or respiratory condition preventing use of systemic chemotherapy
- Major surgery within 28 days before enrollment (except diverting colostomy)
- History of inflammatory bowel disease requiring significant intervention
- Prior allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin
- Known dipyrimidine dehydrogenase deficiency
- Evidence of distant metastases (M1)
- Pregnant or breastfeeding
- Medical, psychological, or social conditions increasing risk or limiting adherence to study requirements
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Actively Recruiting
2
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
3
VCU Community Memorial Healthcenter
South Hill, Virginia, United States, 23970
Actively Recruiting
Research Team
M
Massey IIT Research Operations, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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