OncoMatch

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.

Phase 3RecruitingNational Cancer Center Hospital EastNCT05646511Data as of May 2026

Treatment: CAPOX · CAPOXIRIThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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