Adjuvant Pressurized IntraPeritonealAerosol Chemotherapy (PIPAC) in resectedhigh risk colon cancer patients.- The PIPAC-OPC3 CC trial - - The PIPAC-OPC3 Trial

Kirurgisk Afdeling A, Odense Universitetshospital0 个研究点目标入组 60 人开始时间: 2017年6月24日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with
•high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1
•with radically resected PM including ovarian metastases
•Performance status 0-1
•Fertile women must use approved contraceptives (see below)
•Version 1, 18.06.2017 7
•Age > 18 years
•Written informed consent
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Radiologically or clinically proven relapse.
•Previous cytoreductive surgery (CRS) with HIPEC
•Other malignant diagnosis within the last 2 years
•Contraindications to laparoscopy (e.g. severe adhesions, peritonitis)
•A history of allergic reaction to oxaliplatin or other platinum containing compounds
•Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault Equation).
•Myocardial insufficiency, defined as NYHA class > 2.
•Impaired liver function defined as bilirubin = 1.5 x UNL (upper normal limit).
•Inadequate haematological function defined as ANC = 1.5 x 109/l and platelets = 100 x
•Any other condition or therapy, which in the investigator’s opinion may pose a risk to the
•patient or interfere with the study objectives.

发起方

Kirurgisk Afdeling A, Odense Universitetshospital