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NCT06107920RecruitingPhase 3

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)

Source: ClinicalTrials.gov · Last updated 10 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
232 (estimated)
First submitted
25 Oct 2023
Start date
7 May 2024
Primary completion date
Aug 2031
Lead sponsor
University Hospital, Rouen
NCT number
NCT06107920
EU CT number
2024-516456-17-00
EudraCT number
2021-002588-23

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 232
  • From 7 May 2024 to the primary completion date, Aug 2031
  • 35 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient having received radiation therapy prior to surgery
  • Contraindication to study neoadjuvant chemotherapy treatments

Other illness

  • Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery
  • History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1
  • Presence of inflammatory bowel disease, HNPCC syndrome or polyposis Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, or high risk of uncontrolled arrhythmia
  • Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
  • Any significant disease, which, in the investigator's opinion, would exclude the patient from the study.

Other

  • Contraindication to colectomy and/or anesthesia
  • Metastatic spread at baseline assessment (lung, liver, peritoneal)
  • Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)
  • Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 6 months after the treatment termination
  • Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
  • Simultaneous participation in another interventional research

Who the study is looking for

  • Age ≥ 18 years
  • ECOG performance status 0 or 1
  • Patients with obstructive colon cancer treated by defunctioning stoma
  • Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge- left transverse colon) - MSS/pMMR (microsatellites stable primary tumor) status
  • Patient requiring colectomy
  • Laboratory data including : White blood cell count ≥ 3.109 /L with Neutrophils ≥ 1,5.109 / L, Platelet count ≥ 100.109 / L, Hemoglobin ≥ 9 g/dL (5,6 mmol/L), Total bilirubin ≤ 1,5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2,5 x ULN, Alkaline phosphatase ≤ 1,5 x ULN, Serum creatinine ≤ 1,5 x ULN (performed 10-15 days prior to randomization).
  • Non metastatic colon cancer (lung, liver, peritoneal) on thoracic-abdomino-pelvis CT scan
  • Absence of synchronous colorectal cancer
  • No prior chemotherapy or abdominal or pelvic irradiation
  • No history of colorectal cancer
  • No serious medical co-morbidity : uncontrolled inflammatory bowel disease, uncontrolled angina, recent \[within the past 6 months\] myocardial infarction, or another serious medical condition, judged to compromise ability to tolerate chemotherapy and/or surgery
  • Women of childbearing potential with effective contraception will be required during chemotherapy treatment and for 6 months after cessation of chemotherapy treatment and a negative blood pregnancy test by beta-HCG at inclusion.
  • Women surgically sterile (absence of ovaries and/or uterus)
  • Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
  • For men participating in the study, contraception is required during the trial and for 6 months after stopping chemotherapy treatment.
  • Patient able to comply with the study protocol, in the investigator's judgment
  • Patient affiliated with, or beneficiary of a social security (national health insurance) category
  • Person informed and having signed his consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens Picardie
Coordinator of this site? Confirm its status
Amiens Cedex 1FranceRecruiting
Centre Hospitalier Simone Veil De Beauvais
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BeauvaisFranceRecruiting
CHU Besançon
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BesançonFranceRecruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Bobigny CedexFranceRecruiting
Hôpital Ambroise-Paré
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Boulogne-BillancourtFranceRecruiting
Centre Hospitalier Régional et Universitaire de Brest
Coordinator of this site? Confirm its status
BrestFranceRecruiting
Centre Hospitalier Universitaire De Caen Normandie
Coordinator of this site? Confirm its status
Caen Cedex 9FranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Chambray Les ToursFranceRecruiting
Centre Hospitalier De Colmar
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Colmar CedexFranceRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceRecruiting
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
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GrenobleFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Centre Hospitalier De Versailles
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Le Chesnay CedexFranceRecruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceRecruiting
Hopital Huriez
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Lille CedexFranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
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ParisFranceRecruiting
Hopitaux Universitaires Pitie Salpetriere
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Paris Cedex 13FranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 15FranceRecruiting
Centre Hospitalier De Pau
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Pau CedexFranceRecruiting
Centre Hospitalier Universitaire De Bordeaux
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Pessac CedexFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceRecruiting
Centre Hospitalier Universitaire Rouen
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RouenFranceRecruiting
Centre Hospitalier Universitaire De La Reunion
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St DenisFranceRecruiting
Centre Hospitalier General De St Denis
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St Denis CedexFranceRecruiting
Institut de Cancérologie Strasbourg Europe
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StrasbourgFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
CHRU De Nancy
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Vandoeuvre Les Nancy CedexFranceRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.