External beam radiotherapy for unresectable hepatocellular carcinoma. A multicenter phase I/II trial. - Radiotherapy in HCC

SAKK - Swiss Group for Clinical Cancer Research0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1.patient must give informed consent before registration
•2.confirmed diagnosis of HCC
•3.stage: cT2-4, cN0-1, M0 or unresectable cT1,cN0-1,M0
•4.cirrhosis Child-Pugh class A or B
•5.measurable disease
•6.residual liver volume: >= 800 ml or >= 40% of total liver volume
•7.WHO 0-2
•8.adequate hematological volumes
•9.adequate hepatic functions
•10.adequate coagulation parameter
•11.adequate renal function
•12.age >= 18
•13.ability to tolerate proton-pump inhibitors or H2 antagonists during RT
•14.women:not pregnant and adequate contraception must be used; men: agree not to father a child during/ within 4 months after trial
•15. compliance and geographic proximity to allow proper staging and follow-up
•16. phase I only:adequate pancreatic function

•1.previous malignancy within 5 years
•2.previous RT to the abdomen or caudal chest
•3.TACE, RFA or RT within 8 weeks before registration
•4. concurrent treatment with other experimental drugs or other anti-cancer therapy
•5.operable disease (curative intent) or planned liver transplantation
•6.nutritional intake < 1500 kcal/day
•7.weight loss > 15%
•8.presence of clinical ascites
•9.presence of encephalopathy
•10.recent myocard infarction
•11.esophageal varices >or = gr 3
•12.syptoms of colitis, enteritis, esophagitis, fistula, gastristis, ileus, necrosis, perforation, stricture or ulcer
•13.severe anorexia, constipation, dehydration, diarrhea or vomiting
•14.any serious underlyuing condition which could impair teh ability of the patient to participate in the trial
•15.concommitant treatment with steroids or NSAIDs durinng RT
•16.psychiatric disorder precluding understanding of information on trial related topics or giving informed consent

发起方

SAKK - Swiss Group for Clinical Cancer Research