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

Phase 3

Completed

Conditions: metastases of peritoneum
peritoneal carcinomatosis
10017990
10027476
10017998

Registration Number: NL-OMON47140

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 185

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.

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 *mol/l. (12) Pernicious anemia or other anaemias due to vitamin B12 deficiency.(13) peripheral sensory neuropathy with functional impairment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is peritoneal recurrence-free survival at 18 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are treatment related toxicity, incidence of PC,<br /><br>sensitivity of imaging to detect PC during follow-up, differences in patterns<br /><br>of dissemination (peritoneal plus or minus distant metastases), disease-free<br /><br>survival, overall survival, quality of life and costs.</p><br>