Adjuvant hyperthermic intraperitoneal chemotherapy in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicenter trial

INTERVENTION: Trade Name: Oxaliplatine Product Name: oxaliplatin Pharmaceutical Form: Concentrate and solvent for solution for infusion Trade Name: Rescuvolin Product Name: Leucovorin Pharmaceutical Form: Solution for injection Trade Name: 5‐fluorouracil Product Name: 5‐fluorouracil Pharmaceutical Form: Concentrate for solution for injection/infusion CONDITION: Adjuvant hyperthermic intraperitoneal chemotherapy in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicenter trial Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The aim is to determine the effectiveness of adjuvant HIPEC using oxaliplatin following a curative resection of a pT4 or intra‐abdominally perforated CRC in preventing the development of PC in comparison to the standard adjuvant systemic treatment Primary end point(s): Primary endpoint is peritoneal recurrence‐free survival at 18 months. Secondary Objective: Secondary endpoints are treatment related toxicity, incidence of PC, sensitivity of imaging to detect PC during follow‐up, differences in patterns of dissemination (peritoneal plus or minus distant metastases), disease‐free survival, overall survival, quality of life and costs. Timepoint(s) of evaluation of this end point: 18 months SECONDARY OUTCOME: Secondary end point(s): • Treatment related toxicity, including 30‐day complication rate and re‐admission rate ; • Hospital stay ; • Incidence of Peritonis carcinomatosa (PC) ; • Sensitivity of imaging to detect PC during follow‐up ; • Differences in patterns of dissemination (peritoneal plus or minus distant metastases) ; • Disease‐free survival ; • Overall survival ; • Quality of life ; • Costs ; • PC during diagnostic laparoscopy at 18 months ; Timepoint(s) of evaluation of this end point: 3, 6, 12, 18, 24, 36, 48 and 60 months INCLUSION CRITERIA: (1) age between 18 and 75 years. (2) adequate clinical condition to undergo re‐laparoscopy or re‐laparotomy within either 10 days or between week 5‐8 from primary resection. (3) written informed consent (4) white blood cell count at least 3000/mm3, platelet count at least 100.000/mm3. (5) no bleeding diathesis or coagulopathy. (6) creatinine normal or creatinine clearance at least 50 ml/min. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 158