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 (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT04288999 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior surgery, pelvic irradiation disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger and at least 20 years old.
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