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

Academic Medical Center0 个研究点目标入组 176 人开始时间: 2014年9月1日最近更新: 2015年1月12日

适应症

试验速览

暂无简介。

•(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.

发起方

Academic Medical Center