Patients first treated by stoma and requiring chemotherapy for obstructive colon cancer MedDRA version: 20.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10073254 Term: Neoadjuvant therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: ELOXATINE 5 mg/ml, solution à diluer pour perfusion
Product Name: ELOXATINE 5 mg/ml, solution à diluer pour perfusion
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Oxalip
Sponsors
CHU de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 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- left transverse colon) – MSS (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 (lung, liver, peritoneal) on thoracic-abdomino-pelvis CT scan 8. Absence of synchronous colorectal cancer 9. No prior chemotherapy or abdominal or pelvic irradiation 10. No history of colorectal cancer 11. No serious medical co-morbidity (e.g., 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 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 ?-HCG at inclusion. 13. Women surgically sterile (absence of ovaries and/or uterus) 14. Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) 15. For men participating in the study, contraception is required during the trial and for 6 months after stopping chemotherapy treatment. 16. Patient able to comply with the study protocol, in the investigator’s judgment 17. Patient affiliated with, or beneficiary of a social security (health insurance) category 18. Person informed and having signed his consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: 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. Metastatic spread at baseline assessment (lung, liver, peritoneal) 4. 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) 5. Known hypersensitivity reaction to any of actives ingredients or any of excipients of study chemotherapy treatments 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 6 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether CAPOX or FOLFOX neoadjuvant chemotherapy in a 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.;Secondary Objective: Tolerability (grade 3-4 toxicity) and compliance (number of cycles) of neoadjuvant chemotherapy -Tolerability of adjuvant chemotherapy (grade 3-4 toxicity) -Primary tumour resection (rate, Quality and completeness of the surgical excision) -Postoperative morbidity according to Dindo classification [51] -Disease-free survival at 3 years -Overall survival at 3 years -Survival without stoma at 3 years -Quality of life at J0, week5 (FOLFOX) / week7 (CAPOX), week9 (FOLFOX) and every 6 months a year ;Primary end point(s): The primary endpoint of this study is the full curative therapeutic;Timepoint(s) of evaluation of this end point: last visit of the participant is 36 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The study's secondary criteria are as follows: - Adverse events (grade 3,4 and 5 toxicity) related to neoadjuvant chemotherapy including those related to the primary tumor - Adverse events (grade 3, 4, and 5 toxicity) related to adjuvant chemotherapy including those related to the primary tumor - Number of cycles administered of neoadjuvant chemotherapy - Rate of primary tumour resection - Quality and completeness of the surgical excision (number of lymph nodes examined, completeness of the mesocolon, margins) - Overall morbidity according to the Dindo classification [70] at 60 days postoperatively. All complications occurring during hospitalization will be collected. Last complications occurring after hospitalization will be collected during follow-up. - Overall mortality at 3 years, mortality without relapse at 3 years and mortality without stoma at 3 years. Quality of life evaluated using EORTC QLQ-C30 and QLQ-CR29 dedicated to CRC at J0, week5 (FOLFOX)/week7 (CAPOX), week9 (FOLFOX) and every 6 months a year.;Timepoint(s) of evaluation of this end point: last visit of the participant is 36 months after randomization | — |
Countries
France
Contacts
Public ContactJulie RONDEAUX
CHU de Rouen
Outcome results
None listed