Systemic therapy with or without radiation therapy in unresectable non metastatic gall bladder carcinoma open label parallel arm phase 2 phase 3 integrated randomized clinical trial (RUGB) - RUGB

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1 Histologically proven biopsy or cytology adenocarcinoma of gall
•bladder. Gall bladder neck primaries with hilar block mimicking hilar
•cholangiocarcinoma will also be included
•2 Non metastatic at presentation as determined using cross sectional
•imaging and diagnostic laparoscopy if done as a part of standard work up
•recommended in the joint clinic
•3 Locally advanced disease with one or more of the following
•4 Extensive liver infiltration not amenable for surgery but feasible for safe
•radiation delivery -Liver minus gross tumor volume at least 700cc
•5 Vascular involvement encasement more than 180-degree angle of one of the
•vessels Hepatic artery main portal vein right or left portal vein
•6 Obstructive jaundice with hilar involvement (type 2 non communicating
•block and higher blocks as per Bismuth-Corlette classification)
•7 Stable disease or partial response-RECIST 1.1 after initial 3 months of
•Gemcitabine based chemotherapy
•8 Eastern Cooperative Oncology Group performance status of 0 1 or 2 fit for chemotherapy
•9 Normal hematological and renal and hepatic functions allowing safe delivery of chemotherapy

•1 Patients with distant metastasis including non regional lymph nodes metastasis will be excluded
•2 Prior abdominal therapeutic radiation
•3 Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
•4 Pregnancy or Lactating women

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