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OncoMatch/Clinical Trials/NCT05939661

A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer

Is NCT05939661 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chemotherapy for rectal cancer.

Phase 2RecruitingOsaka UniversityNCT05939661Data as of May 2026

Treatment: ChemotherapyA multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage CT2N0M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: extensive surgery

Exception: excluding CV port placement

extensive surgery (excluding CV port placement) within 4 weeks

Cannot have received: anticancer therapy

Any anticancer therapy within 4 weeks

Cannot have received: radiation therapy

Radiation within 4 weeks

Lab requirements

Blood counts

Neutrophil count: >= 1,500/mm3; Platelet count: >= 10.0 x 10^4 /mm3; Hemoglobin: >=9.0 g/dL

Kidney function

Serum creatinine: 1.5x or less than ULN or creatinine clearance: 45 mL/min or more

Liver function

Total bilirubin: 1.5x or less than ULN; AST, ALT, ALP: 2.5x or less than ULN

criteria for major organ function within 14 days prior to registration: Neutrophil count: >= 1,500/mm3; Platelet count: >= 10.0 x 10^4 /mm3; Hemoglobin: >=9.0 g/dL; Total bilirubin: 1.5x or less than ULN; AST, ALT, ALP: 2.5x or less than ULN; Serum creatinine: 1.5x or less than ULN or creatinine clearance: 45 mL/min or more

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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