Authorised Therapeutic confirmatory (Phase III) patients admitted for an obstructive colon cancer

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

EU CTIS ID: 2024-516456-17-00

What this study is testing

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.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Age ≥ 18 years
10. No history of colorectal cancer
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. 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. For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment
14. Patient able to comply with the study protocol, in the investigator’s judgment

You likely can't join if

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
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

See the full eligibility criteria

Who can join

1. Age ≥ 18 years
10. No history of colorectal cancer
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. 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. For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment
14. Patient able to comply with the study protocol, in the investigator’s judgment
15. Patient affiliated with, or beneficiary of a social security (health insurance) category
16. Person informed and having signed his consent
2. ECOG performance status 0 or 1
3. Patients with obstructive colon cancer treated by defunctioning stoma
4. Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge) MSS/pMMR (microsatellite stable primary tumor) status
5. Patient requiring colectomy
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. Non metastatic colon cancer on thoracic-abdomino-pelvis CT scan
8. no suspicion of 2nd colon cancer
9. No prior chemotherapy or abdominal or pelvic irradiation

What rules you out

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
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. 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)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.