RecruitingPhase 3NCT06107920

Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy

Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy : A Randomized Phase III Trial - COnCERTO (French 01-18)


Sponsor

University Hospital, Rouen

Enrollment

232 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to determine whether chemotherapy prior to tumor removal (neoadjuvant chemotherapy), in patients undergoing treatment for colon cancer in occlusion (CCO), would improve the rate of patients able to benefit from "optimal" treatment, i.e. complete treatment (including all neoadjuvant and adjuvant chemotherapy cures). This new strategy, which would combine chemotherapy before surgery and possibly post-operatively (depending on tumor analysis), could improve the prognosis of occluded colon cancers by treating circulating micrometastases and/or inducing a reduction in tumor size, thereby increasing the rate of complete resection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving chemotherapy before surgery (neoadjuvant chemotherapy) to patients with a bowel-blocking colon cancer — who already had a temporary colostomy placed to relieve the blockage — leads to better outcomes than going straight to surgery. **You may be eligible if...** - You are 18 or older with a confirmed colon cancer (not rectal) causing a blockage that was treated with a temporary colostomy - Your cancer has not spread to other organs (no metastases) - Your cancer is a specific type (MSS/pMMR adenocarcinoma) - You have not had prior chemotherapy or pelvic radiation - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to the liver, lungs, or lining of the abdomen - You have a rectal cancer (within 10 cm of the anus) - You have inflammatory bowel disease, a hereditary colon cancer syndrome, or recent heart problems - You are pregnant or breastfeeding - You have nerve damage (peripheral neuropathy) 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

DRUGNeoadjuvant chemotherapy

Diverting stoma- neoadjuvant chemotherapy - colectomy - +/- adjuvant chemotherapy


Locations(28)

Chu Amiens

Amiens, France

Chr Beauvais

Beauvais, France

Chru Besancon

Besançon, France

Aphp Avicenne

Bobigny, France

CHU CAEN

Caen, France

Aphp Antoine Beclere

Clamart, France

Chu Colmar

Colmar, France

Chu Dijon

Dijon, France

Chu Grenoble

Grenoble, France

Aphp Kremlin Bicetre

Le Kremlin-Bicêtre, France

Chru Lille

Lille, France

Chru Lille

Lille, France

Chu Limoges

Limoges, France

Aphm La Timone

Marseille, France

Aphm Hopital Nord

Marseille, France

Chru Nancy

Nancy, France

Chu Nantes

Nantes, France

Aphp Saint Antoine

Paris, France

Aphp Cochin

Paris, France

Aphp Georges Pompidou

Paris, France

Gh Diaconesses Croix St Simon

Paris, France

CHU LYON

Pierre-Bénite, France

Ch Poissy

Poissy, France

Chu Rouen

Rouen, France

Ch St Denis

Saint-Denis, France

Chu Strasbourg

Strasbourg, France

Chu Tours

Tours, France

Ch Versailles

Versailles, France

View Full Details on ClinicalTrials.gov

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NCT06107920


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