OncoMatch/Clinical Trials/NCT04495088
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
Is NCT04495088 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for rectal cancer.
Treatment: mFOLFOX (neoadjuvant) · XELOX (neoadjuvant) · mFOLFOX (adjuvant) · XELOX (adjuvant) · Capecitabine (adjuvant) · infusional 5-FU/FA "AIO" regimen (adjuvant) · infusional 5-FU/FA "de Gramont" (adjuvant) — This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage CT1/2 WITH CLEAR CN+, T3A-B, CT3-4 (MRI, EUS, clinical)
MRI-defined inclusion criteria for lower, middle, and upper third of the rectum
Performance status
WHO/ECOG 0–1
Prior therapy
Cannot have received: antineoplastic therapy
Prior antineoplastic therapy for rectal cancer
Cannot have received: radiotherapy
Prior radiotherapy of the pelvic region
Lab requirements
Blood counts
Leukocytes ≥ 3.000/mm³, ANC ≥ 2.000/mm³, platelets ≥ 100.000/mm³, Hb > 9 g/dl
Kidney function
Serum creatinine ≤ 1.5 x upper limit of normal; severe kidney dysfunction (creatinine clearance < 30 ml/min) excluded
Liver function
Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal
Cardiac function
QTc interval (Bazett) ≤ 440 ms; clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment [excluded]
Adequate haematological, hepatic, renal and metabolic function parameters: Leukocytes ≥ 3.000/mm³, ANC ≥ 2.000/mm³, platelets ≥ 100.000/mm³, Hb > 9 g/dl; Serum creatinine ≤ 1.5 x upper limit of normal; Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal; QTc interval (Bazett) ≤ 440 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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