Neoadjuvant Chemotherapy for Obstructive Colon cancER first Treated by cOlostomy : A randomized phase III trial - COnCERTO (French 01-18) 2019/0407/HP

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

7 May 2024 → ongoing

Decision date (initial)

2024-09-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516456-17-00

EudraCT number

2021-002588-23

ClinicalTrials.gov

NCT06107920

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

determine whether CAPOX or FOLFOX neoadjuvant chemotherapy in a perioperative strategy in patients admitted for an OCC (and for whom occlusion was lifted by a discharge stoma), may improve the rate of complete curative therapeutic sequence as compared to an adjuvant chemotherapy strategy.

Secondary objectives 8

1. - Tolerability (grade 3, 4 and 5 toxicity) and compliance (number of cycles) of neoadjuvant chemotherapy
2. - Tolerability (grade 3, 4 and 5 toxicity) of adjuvant chemotherapy
3. - Primary tumour resection (rate, quality and completeness of the surgical excision)
4. - Postoperative morbidity according to Dindo classification
5. - Disease-free survival at 3 years
6. - Overall survival at 3 years
7. - Survival without stoma at 3 years
8. - Quality of life at week5 (FOLFOX)/week7 (CAPOX), week9 (FOLFOX) and every 6 months a year

Conditions and MedDRA coding

patients admitted for an obstructive colon cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 16

1. 1. Age ≥ 18 years
2. 2. ECOG performance status 0 or 1
3. 3. Patients with obstructive colon cancer treated by defunctioning stoma
4. 4. Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge) MSS/pMMR (microsatellite stable primary tumor) status
5. 5. Patient requiring colectomy
6. 6. 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)
7. 7. Non metastatic colon cancer on thoracic-abdomino-pelvis CT scan
8. 8. no suspicion of 2nd colon cancer
9. 9. No prior chemotherapy or abdominal or pelvic irradiation
10. 10. No history of colorectal cancer
11. 11. 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
12. 12. women participating in the study, contraception is required during chemotherapy treatment and for 15 months after cessation of chemotherapy treatment a) For Women of childbearing potential an effective contraception is required and a negative blood pregnancy test by beta-HCG at inclusion and monthly pregnancy tests throughout the study until the end of systemic treatment exposure b) For women surgically sterile the absence of ovaries and/or uterus is confirmed. c) For postmenauposal women a confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) is required
13. 13. For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment
14. 14. Patient able to comply with the study protocol, in the investigator’s judgment
15. 15. Patient affiliated with, or beneficiary of a social security (health insurance) category
16. 16. Person informed and having signed his consent

Exclusion criteria 14

1. 1. Contraindication to colectomy and/or anesthesia 2. Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery 3. Patient having received radiation therapy prior to surgery 4. Metastatic spread at baseline assessment (lung, liver, peritoneal) 5. History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1 common toxicity criteria for adverse events NCI-CTCAE (version 5.0) 6. Contraindication to study chemotherapy treatments 7. Presence of inflammatory bowel disease HNPCC syndrome or polyposis 8. Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia 9. Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency) 10. Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent 11. Any significant disease, which, in the investigator’s opinion, would exclude the patient from the study. 12. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 15 months after the chemotherapy treatment termination 13. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision) 14. Simultaneous participation in another interventional research
2. 2. Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery
3. 3. Patient having received radiation therapy prior to surgery
4. 4. Metastatic spread at baseline assessment (lung, liver, peritoneal)
5. 5. History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1 common toxicity criteria for adverse events NCI-CTCAE (version 5.0)
6. 6. Contraindication to study chemotherapy treatments
7. 7. Presence of inflammatory bowel disease HNPCC syndrome or polyposis
8. 8. Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
9. 9. Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)
10. 10. Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
11. 11. Any significant disease, which, in the investigator’s opinion, would exclude the patient from the study.
12. 12. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 15 months after the chemotherapy treatment termination
13. 13. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
14. 14. Simultaneous participation in another interventional research

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. the success of a full curative therapeutic

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

Nell MARTY

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

Nell MARTY

Locations

1 EU/EEA country · 39 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications