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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 (Jun 2026). This Phase 2 trial studies Chemotherapy for rectal cancer.

Phase 2RecruitingOsaka UniversityNCT05939661Data as of Jun 2026Location: Japan

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

Treatments studied

Other

Chemotherapy

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.

Frequently asked questions

Is NCT05939661 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.

What disease stage is eligible?

Stage CT2N0M0 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.

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