OncoMatch/Clinical Trials/NCT04643366
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
Is NCT04643366 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Chemotherapy for rectal cancer.
Treatment: Chemotherapy — This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T3-4 N0 M0, T ANY N1-2 M0 (AJCC 8th ed.)
Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy
Exception: Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist
Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist
Cannot have received: 5-fluorouracil, leucovorin, or oxaliplatin (5-fluorouracil, leucovorin, oxaliplatin)
Exception: Prior known allergic reaction
Prior known allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL (transfusion/intervention allowed to achieve Hgb ≥8.0 g/dL)
Kidney function
Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft-Gault formula
Liver function
AST and alkaline phosphatase < 2.5 x upper limit of normal (ULN); Bilirubin ≤ 2.5 ULN
Adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dL is acceptable.) Adequate liver and renal function defined as follows: AST and alkaline phosphatase < 2.5 x upper limit of normal (ULN); Bilirubin ≤ 2.5 ULN; Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Virginia Cancer Institute · Richmond, Virginia
- Virginia Commonwealth University Massey Cancer Center · Richmond, Virginia
- VCU Community Memorial Healthcenter · South Hill, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04643366 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy, 5-fluorouracil, leucovorin, or oxaliplatin disqualifies patients from enrollment.
What disease stage is eligible?
Stage T3-4 N0 M0 or T ANY N1-2 M0 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages