OncoMatch/Clinical Trials/NCT05646511
TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
Is NCT05646511 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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: MSI high
MSI-high (MSI-H) or defective mismatch repair (dMMR) is known
Excluded: Mismatch-repair deficient (MSI-H / dMMR)
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.
Frequently asked questions
Is NCT05646511 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require UGT1A1?
Yes, UGT1A1 wild-type is a required biomarker for enrollment.
Does this trial require UGT1A1?
Yes, UGT1A1 single heterozygous is a required biomarker for enrollment.
Are patients with MSH2 alterations eligible?
No. MSH2 defective mismatch repair is an exclusion criterion.
Are patients with MSH6 alterations eligible?
No. MSH6 defective mismatch repair is an exclusion criterion.
What disease stage is eligible?
Stage CT3-4N0M0 or T1-4N1-2M0 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