OncoMatch/Clinical Trials/NCT04288999
Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Is NCT04288999 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Chemotherapy for rectal cancer recurrent.
Treatment: Chemotherapy — JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgical resection — initial rectal cancer
Surgical resection (including local resection, with or without lymph node dissection)
Must have received: endoscopic resection — initial rectal cancer
Endoscopic resection
Cannot have received: surgery
No prior surgery for recurrent rectal cancer.
Cannot have received: pelvic irradiation
No prior pelvic irradiation for any malignancies.
Lab requirements
Blood counts
Neutrophil count ≥ 1,500/mm3; Hemoglobin ≥ 9.0 g/dL; Platelet count ≥ 100,000/mm3
Kidney function
Cr ≤ 1.5 mg/dL
Liver function
Total Bilirubin ≤ 2.0 mg/dL; AST ≤ 100 U/L; ALT ≤ 100 U/L
Sufficient organ function. i) Neutrophil count ≥ 1,500/mm3 ii) Hemoglobin ≥ 9.0 g/dL iii) Platelet count ≥ 100,000/mm3 iv) Total Bilirubin ≤ 2.0 mg/dL v) Aspartate aminotransferase (AST) ≤ 100 U/L vi) Alanine Aminotransferase (ALT) ≤ 100 U/L vii) Cr ≤ 1.5 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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