Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- improvement in 3 year overall survival
研究概览
简要总结
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
详细描述
Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer.
The use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial.
Neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced resectable GBC defined as Clinical T3/4 disease or Regional LN involvement on imaging studies.
- •Post cholecystectomy GBC with residual disease on imaging, History of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, Regional LN involvement on imaging studies.
排除标准
- •Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .
- •Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.
- •Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging.
- •Obstructive jaundice due to involvement of biliary tree by tumour.
- •Vascular involvement such as common hepatic artery, MPV right hepatic artery or right portal vein.
- •Any distant metastasis or isolated port site metastasis
- •Involvement of non-regional LN (e.g . Celiac LN, SMA lymph node, inter-aortocaval or left para-ortic LN).
- •Poor performance status ECOG 3 or more.
- •Inability or unwillingness to follow study protocol
研究组 & 干预措施
upfront surgery
after staging workup and biopsy, patient being taken up for upfront surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification
干预措施: curative surgery (Procedure)
Neoadjuvant chemotherapy followed by surgery
NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0.
干预措施: neoadjuvant chemotherapy (Drug)
Neoadjuvant chemotherapy followed by surgery
NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0.
干预措施: curative surgery (Procedure)
结局指标
主要结局
improvement in 3 year overall survival
时间窗: 3 year
To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer
次要结局
- post operative outcomes(90 days)
研究者
Shaifali Goel
DOCTOR
Rajiv Gandhi Cancer Institute & Research Center, India