Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

Launched by MENOUFIA UNIVERSITY · Feb 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced rectal cancer, which is a type of cancer found in the rectum. The trial is comparing two treatment plans: the standard method, called TNT (which includes a combination of chemotherapy and radiation therapy), and a new method that uses a specific chemotherapy called FOLFIRINOX before surgery. The goal is to see if the new treatment can help shrink the tumor more effectively, making it easier to remove during surgery.

To participate in this trial, patients need to have a confirmed diagnosis of rectal cancer that has not spread to other parts of the body and is at a stage where treatment is possible. Other important factors include being in good overall health without serious heart problems or other major illnesses. Participants can expect to receive close monitoring throughout the trial, and their treatment will be guided by a team of healthcare professionals. If you're considering joining this study, it's important to talk to your doctor to see if it might be a good fit for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically proven rectal adenocarcinoma.
• • 2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.
• • 3. Resectable tumor, or considered as potentially resectable after CRT.
• • 4. No distant metastases.
• • 5. Patient eligible for surgery
• • 6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1.
• • 7. No heart failure or coronary heart disease symptoms (even controlled).
• • 8. No peripheral neuropathy \> grade 1.
• • 9. No prior radiotherapy of the pelvis for any reason and no previous CT
• • 10. No major comorbidity that may preclude the delivery of treatment
• • 11. Adequate contraception in fertile patients.
• • 12. Adequate hematologic function.
• • 13 Adequate hepatic function.
• • 14. Signed written informed consent.
• Exclusion Criteria:
• • 1. Metastatic disease
• • 2. Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
• • 3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
• • 4. Medical history of angina pectoris or myocardial infarction
• • 5. Other concomitant cancer.
• • 6. Pregnant or breast-feeding woman.
• • 7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.