Peritoneal carcinomatosis secondary to a carcinoma of colorectal or appendicular origin MedDRA version: 7.0 Level: LLT Classification code 10039867
Conditions
Interventions
Trade Name: Eloxatin 5mg/ml powder for solution for infusion. vial containing 100mg
Product Name: oxaliplatin
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Eloxatin 5mg/ml powder
Sponsors
Institut jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Colorectal/appendicular adenocarcinoma with suspected or established peritoneal carcinomatosis. The colorectal origin of the carcinomatosis has to be proven by frozen section or definitive pathology, the primary tumor (or the recurrence) must be technically resectable– The origin and/or exact extent of the peritoneal carcinomatosis may be impossible to judge prior to surgery. In case of secondary interventions for carcinomatosis (after primary tumor resection with peroperative discovery of carcinomatosis), a recovery period of at least 3 months between the two interventions has to be respected. In the mean time, the administration of chemotherapy is at the investigator’s discretion, but a chemotherapy-free period of at least 1 month has to be respected before the 2nd intervention. 2. Age > 18 and = 75 years 3. Absence of any severe organ insufficiency 4. Performance status in accordance with ECOG 60% 5. No chemotherapy, nor radiotherapy in the course of the 4 weeks prior to the surgery 6. Not pregnant 7. Appropriate contraception 8. Informed consent obtained 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe or uncontrolled cardiac insufficiency, including recent (< 6 months) occurrence of myocardial infarction, the presence of congestive cardiac insufficiency, of symptomatic angor in spite of optimum medical care, of cardiac arrhythmia requiring medical treatment presenting insufficient rhythm control, or uncontrolled arterial hypertension 2. Active bacterial, viral or fungal infection 3. Active gastro-duodenal ulcer 4. Parenchymal liver disease (any stage cirrhosis) 5. Uncontrolled diabetes 6. Severe obstructive or restrictive respiratory insufficiency 7. Psychiatric pathology capable of affecting their comprehension and judgment faculty; 8. Tumour in the presence of obstruction 9. Evidence of extra-abdominal disease or liver metastasis 10. Peritoneal cancer index (PCI) =25 (determined peroperative)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing the toxicities and side effects (expressed as early and late morbidity and mortality and (S)AE-reporting) associated with peritoneal cancer surgery and with oxaliplatin containing hyperthermic intra-peritoneal chemotherapy.;Secondary Objective: Assessing the survival at one, three and five years, the relapse free survival and the quality of life (QoL) following peritoneal cancer surgery and oxaliplatin containing hyperthermic intra-peritoneal chemotherapy.;Primary end point(s): 1.early ( 30 days post-op) morbidity and mortality 3.SAE-reporting for toxicity | — |
Countries
Belgium
Outcome results
None listed