OncoMatch/Clinical Trials/NCT04495088
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
Is NCT04495088 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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.
Frequently asked questions
Is NCT04495088 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 CT1/2 WITH CLEAR CN+ or T3A-B or CT3-4 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.
Check if I qualifyRelated pages