Actively Recruiting
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
Led by Ralf Hofheinz · Updated on 2026-02-02
550
Participants Needed
1
Research Sites
513 weeks
Total Duration
On this page
Sponsors
R
Ralf Hofheinz
Lead Sponsor
D
Deutsche Krebshilfe e.V., Bonn (Germany)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients with confirmed rectal adenocarcinoma located 0 to 16 cm from the anocutaneous line
- High-resolution pelvic MRI for local cancer staging
- Use of transrectal endoscopic ultrasound to help classify tumor stage
- MRI criteria based on tumor location and stage: lower third: cT1/2 with clear cN+ or T3a-b with CRM > 2mm and EMVI negative; middle third: cT1/2 with clear cN+, or cT3 without tumor adjacent to mesorectal fascia, N0 or N1, EMVI negative; upper third: cT1/2 with clear cN+ or any cT3-4
- Spiral CT scan of abdomen and chest to exclude distant metastases
- Age 18 years or older, no upper age limit
- WHO/ECOG performance status 0 or 1
- Adequate blood counts: leukocytes ≥ 3000/mm³, ANC ≥ 2000/mm³, platelets ≥ 100,000/mm³, hemoglobin > 9 g/dl
- Normal kidney and liver function within specified limits
- QTc interval ≤ 440 ms
- Signed informed consent
You will not qualify if you...
- Presence of distant metastases
- Prior chemotherapy or radiotherapy for rectal cancer
- Major surgery within 4 weeks before enrollment
- Pregnancy, breastfeeding, or planning pregnancy within 6 months after treatment
- Unwillingness to use highly effective contraception during and 6 months after treatment
- Participation in another clinical study within 30 days before enrollment
- History of drug abuse
- Concurrent cancer treatments
- Serious health issues including uncontrolled infections, neurologic or psychiatric disorders
- Significant cardiovascular disease within 6 months prior to enrollment
- Chronic diarrhea greater than grade 1
- Other cancers within 3 years except certain skin and cervical cancers if disease-free
- Known allergies to study drugs or excipients
- Peripheral sensory neuropathy greater than grade 1
- Severe kidney damage (creatinine clearance < 30 ml/min)
- Recent or concurrent treatment with brivudine
- Vitamin B12 deficiency causing anemia
- Known dihydropyrimidine dehydrogenase deficiency
- Conditions that might impair study compliance or follow-up scheduling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Unversity Hospital Mannheim
Mannheim, Germany, 68167
Actively Recruiting
Research Team
R
Ralf-Dieter Hofheinz, Prof. Dr.
CONTACT
M
Michelle Tez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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