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)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Median overall survival
研究概览
简要总结
The goal of this clinical trial is to compare two treatment regimes, namely, systemic therapy (chemotherapy and/or immunotherapy) alone vs. systemic therapy and radiation therapy in patients with inoperable but localized gallbladder cancer. The main questions it aims to answer are: • Whether adding radiation therapy to systemic therapy improves overall survival? • What are the effects on other endpoints like cancer-free intervals, side effects, and quality of life? Participants will be randomly assigned to one of the two treatment regimes mentioned earlier by a computer-based program. Researchers will compare survival and quality of life outcomes between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Median overall survival
时间窗: 2 years
Time interval between the date of diagnosis and death due to any case.
时间窗: 2 years
次要结局
- 1. Progression free survival(Time interval between the date of diagnosis and radiological or histological (whichever earlier) evidence of disease)
研究者
Dr Shivakumar Gudi
Tata Memorial Centre