Actively Recruiting
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
Led by Menoufia University · Updated on 2025-02-19
100
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.
CONDITIONS
Official Title
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven rectal adenocarcinoma.
- Stages cT3 with risk of local recurrence, cT4, or N positive, M0 with multidisciplinary recommendation for total neoadjuvant therapy.
- Resectable tumor or potentially resectable after chemoradiotherapy.
- No distant metastases.
- Eligible for surgery.
- WHO/ECOG performance status 0 or 1.
- No heart failure or coronary heart disease symptoms.
- No peripheral neuropathy greater than grade 1.
- No prior pelvic radiotherapy or chemotherapy.
- No major comorbidity preventing treatment delivery.
- Adequate contraception in fertile patients.
- Adequate hematologic function.
- Adequate hepatic function.
- Signed written informed consent.
You will not qualify if you...
- Metastatic disease.
- Unresectable rectal cancer including prostatic involvement or extension to pelvic floor muscles.
- Contraindication to 5-FU, oxaliplatin, or irinotecan, including Gilbert disease or UGT1A1 genotype.
- History of chronic diarrhea or inflammatory bowel disease.
- History of angina pectoris or myocardial infarction.
- Other active cancers.
- Pregnant or breastfeeding women.
- Any psychological, familial, sociological, or geographical condition interfering with compliance or follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medicine
Shibīn al Kawm, Menoufia, Egypt, 32511
Actively Recruiting
Research Team
E
E Morkos
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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