Intraperitoneal hyperterm chemotherapy as adjuvant treatment to prevent peritoneal carcinomatosis of colorectal origi

Conditions: 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]

Registration Number: EUCTR2014-002794-11-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 176

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

Exclusion Criteria

(1) postoperative complications that interfere with adjuvant HIPEC within 8 weeks (i.e. persisting intra-abdominal abscess, significant fascial dehiscence, enteric fistula). (2) liver and/or lung metastases. (3) pregnant or lactating women. (4) unstable or uncompensated respiratory or cardiac disease. (5) serious active infections. (6) other concurrent chemotherapy. (7) hypersensitivity for fluorouracil folinic acid (calciumfolinate) or another substance of leucovorin or Oxaliplatin. (8) Stomatitis, ulceration in the mouth or gastrointestinal tract. (9) severe diarrhea (10) severe hepatic and / or renal dysfunction. (11) plasma bilirubin concentrations greater than 85 µmol/l. (12) Pernicious anemia or other anaemias due to vitamin B12 deficiency.(13) peripheral sensory neuropathy with functional impairment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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.;Primary end point(s): Primary endpoint is peritoneal recurrence-free survival at 18 months.;Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Treatment related toxicity, including 30-day complication rate and re-admission rate<br>•Hospital stay<br>•Incidence of Peritonis carcinomatosa (PC)<br>•Sensitivity of imaging to detect PC during follow-up<br>•Differences in patterns of dissemination (peritoneal plus or minus distant metastases)<br>•Disease-free survival<br>•Overall survival<br>•Quality of life<br>•Costs<br>•PC during diagnostic laparoscopy at 18 months<br>;Timepoint(s) of evaluation of this end point: 3, 6, 12, 18, 24, 36, 48 and 60 months