Cytoreductive surgery associated with Hyperthermic Intraperitoneal Chemotherapy versus standard Chemotherapy in the treatment of resectable colorectal carcinomatosis. A multicentric open randomized clinical trial.

ISTITUTO ONCOLOGICO VENETO0 个研究点目标入组 122 人开始时间: 2013年1月11日最近更新: 2018年3月5日

适应症

试验速览

暂无简介。

•Histologically documented colorectal carcinomatosis • Minor/moderate peritoneal carcinomatosis with a Peritoneal Cancer Index (PCI) lower than 20 evaluated by CT and/or PET CT imaging • Patient between age 18 and 75 years. • ECOG 1-2 • ASA score 1-2 • Clinical, instrumental and biohumoral signs of bone marrow, hepatic, renal, pulmonary or cardiac insufficiency absent • Patients must be available for follow up • Signed Informed Consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 62

•Extra-peritoneal metastatic localization (retroperitoneum, lymphnodes, liver or lung) • Prior first-line chemotherapy treatment for peritoneal carcinomatosis(adjuvant therapy excluded) • Prior intraperitoneal chemohyperthermic (HIPEC) treatment • Positive history of malignancies for at least 3 years, with the exception of basal cell carcinoma • Evidence of cardiovascular disease (history of congestive heart failure or LVEF <40%) • Evidence of renal disease (creatinine level >1.5 than the normal institutional limits or creatinine clearance <60 mL/min) • Evidence of hepatic disease (ASAT, ALAT, bilirubin >1.5 than the normal institutional limits, PT) • Evidence of hematopoietic disease (WBC <4000/mm3; neutrophil count <1500/mm3; platelets < 80000/mm3) • Evidence of pulomonary disease (BPCO or other restrictive lung disease with FEV1 <50% or a DLCO <40% than the normal limits for age)

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