EVALUATION OF SAFETY AND EFFICACY OF STEREOTACTIC BODY RADIOTHERAPY IN UNRESECTABLE GALL BLADDER CANCER: A PROSPECTIVE COHORT STUDY
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Response assessment following SBRT as per RECIST 1.1 criteria
研究概览
简要总结
Gallbladder cancer is the most common biliary tract malignancy and the fifth leading gastrointestinal cancer worldwide.The overall response rate with chemotherapy and radiotherapy alone are 38.4 and 26 respectively Chemotherapy gemcitabine plus cisplatin is the standard treatment for unresectable advanced GBC, though outcomes remain poor. The role of chemoradiotherapy following chemotherapy is still unclear The major limitation of conventional external beam radiotherapy is the sensitivity of the liver and adjacent gastrointestinal structures. In contrast, SBRT offers a highly precise, safe, and effective option for treating hepatobiliary and pancreatic cancers Additionally, SBRT delivers higher biological effective doses of radiation in fewer sessions, typically completing treatment in 1 to 5 sessions, compared to the several weeks required for CRT This shorter treatment duration is especially advantageous for patients with poor general health or advanced cancers The fewer day of radiation with SBRT offers fewer days off of systemic therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with ECOG PS 0-2 histologically proven unresectable non metastatic gallbladder cancer.
排除标准
- •Patients with distant metastasis at presentation Prior radiotherapy, Pregnant patients.
- •Bilirubin more than 5mg/Dl.Liver enzymes three times or more above the upper limit of normal.
- •one or more than one comorbidities.
结局指标
主要结局
Response assessment following SBRT as per RECIST 1.1 criteria
时间窗: 6 weeks after completion of SBRT
次要结局
- Acute Gastrointestinal toxicity as per RTOG criteria(During treatment & till 6 weeks following SBRT)
- To assess resectability following SBRT(After 6 weeks of SBRT)
研究者
Dr. Manisha Kumari
Department of Radiation Oncology. All India Institute of Medical Sciences, Bhubaneswar