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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Amiens
RECRUITING
Amiens
Chr Beauvais
RECRUITING
Beauvais
Chru Besancon
RECRUITING
Besançon
Aphp Avicenne
RECRUITING
Bobigny
CHU CAEN
RECRUITING
Caen
Aphp Antoine Beclere
RECRUITING
Clamart
Chu Colmar
RECRUITING
Colmar
Chu Dijon
RECRUITING
Dijon
Chu Grenoble
RECRUITING
Grenoble
Aphp Kremlin Bicetre
RECRUITING
Le Kremlin-bicêtre
Chru Lille
RECRUITING
Lille
Chru Lille
RECRUITING
Lille
Chu Limoges
RECRUITING
Limoges
Aphm Hopital Nord
RECRUITING
Marseille
Aphm La Timone
RECRUITING
Marseille
Chru Nancy
RECRUITING
Nancy
Chu Nantes
RECRUITING
Nantes
Aphp Cochin
RECRUITING
Paris
Aphp Georges Pompidou
RECRUITING
Paris
Aphp Saint Antoine
RECRUITING
Paris
Gh Diaconesses Croix St Simon
RECRUITING
Paris
CHU LYON
RECRUITING
Pierre-bénite
Ch Poissy
RECRUITING
Poissy
Chu Rouen
RECRUITING
Rouen
Ch St Denis
RECRUITING
Saint-denis
Chu Strasbourg
RECRUITING
Strasbourg
Chu Tours
RECRUITING
Tours
Ch Versailles
RECRUITING
Versailles
Contact Information
Primary
Valérie Bridoux
valerie.bridoux@chu-rouen.fr
0232881347
Backup
Julie Rondeaux, PhD
julie.rondeaux@chu-rouen.fr
0232885427
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2031-08
Participants
Target number of participants: 232
Treatments
No_intervention: Arm I (Adjuvant chemotherapy) / Control arm
Diverting stoma - colectomy - +/- adjuvant chemotherapy~The colectomy (open or laparoscopic) should be performed within 1 to 20 days after the randomization and with respect of the oncological quality criteria of resection. After completion of surgery, adjuvant chemotherapy will be discussed as follow:~* Low-risk stage II: No adjuvant treatment~* High-risk MSS stage II (vascular emboli, lymphatic or perinervous invasion, poor differentiation, \<12 harvested lymph nodes, perforation): Investigator's discretion~* pT1-T3N1: CAPOX (3 months) or FOLFOX (6 months)~* pT4 and/or N2: FOLFOX (6 months)
Experimental: Arm II (Neoadjuvant Chemotherapy) / Experimental arm
Patients receive systemic CAPOX or FOLFOX chemotherapy (3 months) within 21 days after the randomization. After completion of neoadjuvant chemotherapy and within 3 to 5 weeks, the colectomy (open or laparoscopic) will be performed with respect of the oncological quality criteria. Adjuvant chemotherapy will be discussed as follow:~* Low-risk stage II: No adjuvant treatment~* High-risk MSS stage II (vascular emboli, perinervous or lymphatic invasion, poor differentiation, \<12 harvested lymph nodes, perforation): Investigator's discretion~* Stage III: CAPOX or FOLFOX (3 months)
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov