RecruitingPhase 2NCT06812728

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.


Sponsor

Menoufia University

Enrollment

100 participants

Start Date

Jan 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a total neoadjuvant therapy (TNT) approach for locally advanced rectal cancer — giving both chemotherapy (FOLFIRINOX) and chemoradiation before surgery, rather than just one upfront. The goal is to shrink the tumor as much as possible before removal and reduce the chance of it coming back. **You may be eligible if...** - You have been diagnosed with rectal cancer confirmed by biopsy (adenocarcinoma) - Your cancer is locally advanced but has not spread to distant organs - Your cancer is considered resectable (able to be surgically removed) - Your general health is good (ECOG performance 0 or 1) - Your heart, nerve, blood, and liver function are adequate for chemotherapy **You may NOT be eligible if...** - You have had prior radiation to the pelvis or prior chemotherapy - You have heart failure, active coronary disease, or peripheral neuropathy above grade 1 - You have significant other health conditions preventing treatment - You are pregnant without adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFIRINOX

Neoadjuvant chemotherapy

DRUGmFolfox6

Neoadjuvant chemotherapy


Locations(1)

Medicine

Shibīn al Kawm, Menoufia, Egypt

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NCT06812728


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