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OncoMatch/Clinical Trials/NCT06162650

Total Neoadjuvant Therapy in Rectal Cancer

Is NCT06162650 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies mFOLFOX6 for rectal cancer.

Phase 2RecruitingNational Cheng-Kung University HospitalNCT06162650Data as of May 2026

Treatment: mFOLFOX6In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage II, III

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: chemotherapy

No prior chemotherapy, radiotherapy or surgery for rectal cancer

Cannot have received: radiotherapy

No prior chemotherapy, radiotherapy or surgery for rectal cancer

Cannot have received: surgery

No prior chemotherapy, radiotherapy or surgery for rectal cancer

Cannot have received: pelvic radiotherapy

Patients who have received prior pelvic radiotherapy

Lab requirements

Blood counts

anc ≥1,500/μl; hb ≥8.0 gm/dl; platelet 100,000/mm3

Kidney function

creatinine ≤1.5x upper normal limit

Liver function

total bilirubin ≤1.5x upper normal limit; ast ≤3x upper normal limit; alt ≤3x upper normal limit

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

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