OncoMatch/Clinical Trials/NCT04643366
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
Is NCT04643366 recruiting? Yes, currently enrolling (Sep 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 (other)
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
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)
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 or other intervention to achieve Hgb ≥8.0 g/dL is acceptable)
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: ANC ≥ 1,200 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL. Adequate liver and renal function defined as follows: AST and alkaline phosphatase < 2.5 x ULN; Bilirubin ≤ 2.5 ULN; CrCl > 30 mL/min
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
- VCU Health Tappahannock Hospital · Tappahannock, 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