OncoMatch/Clinical Trials/NCT05646511
TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
Is NCT05646511 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including CAPOX and CAPOXIRI for locally advanced rectal cancer.
Treatment: CAPOX · CAPOXIRI — This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: UGT1A1 wild-type
UGT1A1 is wild-type or single heterozygous
Required: UGT1A1 single heterozygous
UGT1A1 is wild-type or single heterozygous
Excluded: MSH2 defective mismatch repair
MSI-high (MSI-H) or defective mismatch repair (dMMR) is known
Excluded: MSH6 defective mismatch repair
MSI-high (MSI-H) or defective mismatch repair (dMMR) is known
Excluded: MLH1 defective mismatch repair
MSI-high (MSI-H) or defective mismatch repair (dMMR) is known
Excluded: PMS2 defective mismatch repair
MSI-high (MSI-H) or defective mismatch repair (dMMR) is known
Excluded: MSI high
MSI-high (MSI-H) or defective mismatch repair (dMMR) is known
Disease stage
Required: Stage CT3-4N0M0, T1-4N1-2M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy to the pelvis
No history of radiation therapy to the pelvis, including treatment for other cancer types
Lab requirements
Blood counts
Neutrophil count: ≥1,500/mm3; Platelet count: ≥10.0×10^4/mm3; Hemoglobin concentration: ≥9.0 g/dL
Kidney function
Serum creatinine: Creatinine clearance ≥30 mL/min (by Cockcroft & Gault formula)
Liver function
Total bilirubin: ≤2.0 mg/dL; AST: ≤100 IU/L; ALT: ≤100 IU/L
Criteria for major organ function within 28 days prior to enrollment. ... Neutrophil count: ≥1,500/mm3; Platelet count: ≥10.0×10 4/mm3; Hemoglobin concentration: ≥9.0 g/dL; Total bilirubin: ≤2.0 mg/dL; AST: ≤100 IU/L; ALT: ≤100 IU/L; Serum creatinine: Creatinine clearance ≥30 mL/min (by Cockcroft & Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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