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

Academic Medical Center0 sites176 target enrollmentSeptember 1, 2014

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adjuvant hyperthermic intraperitoneal chemotherapy in patients with colon cancer at high risk of peritoneal carcinomatosis
Sponsor: Academic Medical Center
Enrollment: 176
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

September 1, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Academic Medical Center

•(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

•(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.