Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC (ICC/ECC) - A Phase III Study of the German Registry of Incidental Gallbladder Carcinoma Platform (GR) - The AIO/ CALGP/ ACO- GAIN-Trial -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Primary efficacy endpoint is overall survival (OS)
研究概览
简要总结
Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC)
详细描述
The aim of the study is to investigate whether induction chemotherapy followed by radical re-resection (and - if possible - postoperative chemotherapy) in incidental gallbladder carcinoma (IGBC) or in front radical resection in biliary tract cancer (BTC) (intrahepatic cholangiocarcinoma (ICC)/ extrahepatic cholangiocarcinoma (ECC)) prolongs overall survival without impaired quality of life compared to immediate radical surgery alone with or without adjuvant chemotherapy (investigator's choice) in patients with IGBC, or BTC (ICC/ECC). One of the most important secondary objectives is to raise awareness for the necessity of a radical second surgery as well as to improve the adherence to the treatment guidelines in IGBC. Further secondary objectives are safety and tolerability of the treatment as well as quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A (gemcitabine plus cisplatin)
Patients assigned to arm A will receive treatment with gemcitabine plus cisplatin. Chemotherapy will be administered for 3 cycles preoperatively (neoadjuvant part) and for 3 cycles postoperatively (adjuvant part).
干预措施: Gemcitabine (Drug)
Arm A (gemcitabine plus cisplatin)
Patients assigned to arm A will receive treatment with gemcitabine plus cisplatin. Chemotherapy will be administered for 3 cycles preoperatively (neoadjuvant part) and for 3 cycles postoperatively (adjuvant part).
干预措施: Cisplatin (Drug)
Arm A (gemcitabine plus cisplatin)
Patients assigned to arm A will receive treatment with gemcitabine plus cisplatin. Chemotherapy will be administered for 3 cycles preoperatively (neoadjuvant part) and for 3 cycles postoperatively (adjuvant part).
干预措施: Oncologically radical margin-free (R0) resection (Procedure)
Arm B (standard postoperative management)
Patients assigned to arm B will receive surgery directly, without receiving perioperative chemotherapy (Standard of Care / SOC). After surgery, adjuvant chemotherapy can be administered by investigator's choice.
干预措施: Oncologically radical margin-free (R0) resection (Procedure)
Arm B (standard postoperative management)
Patients assigned to arm B will receive surgery directly, without receiving perioperative chemotherapy (Standard of Care / SOC). After surgery, adjuvant chemotherapy can be administered by investigator's choice.
干预措施: Adjuvant chemotherapy (Drug)
结局指标
主要结局
Primary efficacy endpoint is overall survival (OS)
时间窗: up to 6 years follow-up
次要结局
- Number of patients with any serious perioperative morbidity or mortality(up to 30 and 90 days after surgery)
- PFS (Progression free surviva) rates at 3 and 5 years(at 3 and 5 years after randomization)
- Toxicity, graded using CTC adverse events criteria version CTCAE V 5.0(up to 6 years after randomization)
- Quality of life (EORTC QLQ-C30)(every 3 weeks until EOT andt then every 3 months up to 6 years of follow-up)
- OS (overall survival) rates at 3 and 5 years(at 3 and 5 years after randomization)
- Progression free survival (PFS)(up to 6 years after randomization)
- R0- resection rate(2 weeks after surgery (Arm A: 14 weeks after randomization; Arm B: 2 weeks after randomization))