Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer - PICH

ICANCER0 个研究点目标入组 264 人开始时间: 2012年12月17日最近更新: 2013年5月13日

适应症

试验速览

暂无简介。

•1) Histologically confirmed colorectal cancer,
•2) Minimal or moderate peritoneal carcinosis with a Sugarbaker peritoneal score ? à 25 (see
•annex 9), (peroperatory assessment),
•3) A surgically obtained tumor reduction, macroscopically complete R1 or with a residual
•thickness not exceeding 1 mm (R2), (peroperatory assessment)
•4) Absence of extra peritoneal metastases including hepatic and pulmonary metastases (
•confirmed by a PET scan, if possible),
•5) Patient to be treated by systemic chemotherapy for its carcinosis,
•6) 18 ? age ? 70 yo,
•7) WHO performance status ? 1,
•8) Life expectancy > 12 weeks,
•9) Adequate hematological function: polynuclear neutrophiles ? 1,5x10
•/L, platelets ? 100x10
•10) Adequate hepatic function : total bilirubin ? 1,5 x ULN, ASAT (SGOT) and ALAT (SGPT) ? 3 x
•ULN, alkaline phosphatases ? 3 x ULN,
•11) Seric creatinine ? 1,25 x ULN,
•12) Operable patient,
•13) Peripheral neuropathy with grade ? 3 (CTC AE v3.0 annex 7)
•14) Patient information and written informed consent form signed before any protocol specific
•procedure is started.
•15) Patient is affiliated with a proper/French national health insurance fund
•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 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•1) Carcinosis of other-than-colorectal origin, specifically appendiculary carcinomas,
•2) Large volume carcinosis with Sugarbaker peritoneal-extent score >25 (annex 9), (peroperatory
•assessment)
•3) Patient has already been treated by chemohyperthermia
•4) History of previous cancer (except cutaneous basocellular carcinoma or in situ carcinoma of
•the uterine cervix) with a relapse occurred within the 5-year period prior to inclusion,
•5) Patient already included in another first-line therapeutic trial aimed at the same disease study,
•6) Pregnant women, women who are likely to become pregnant or are breast-feeding,
•7) Individual deprived of liberty or placed under the authority of a tutor,
•8) Patients with any psychological, familial, sociological or geographical condition potentially
•hampering compliance with the study protocol and follow-up schedule.

发起方

ICANCER