Adjuvant Chemotherapy versus Adjuvant Chemotherapy/Radiotherapy for Carcinoma Gallbladder- A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall survival; Recurrence free survival
研究概览
简要总结
The study is a prospective , double arm, single centric, randomized control trial to compare the benefits of adjuvant Chemotherapy versus adjuvant Chemotherapy/Radiotherapy for Carcinoma Gallbladder in 150 consecutive patients of potentially resectable GBC (Gall bladder cancer) who achieved R0 resection and did not recieve any neoadjuvant treatment. Our hypothesis is that patients who recieved adjuvant concurrent chemoradiation have superior overall survival. Our primary outcome would be to measure overall survival and recurrence free survival, and secondary outcome would be to know about the pattern of recurrence and study toxicity/complications of chemotherapy and chemoradiotherapy. Patients will be randomized to either arm after completion of 3 weeks from surgery. At present there is no standard protocol for adjuvant treatment after curative resection of gall bladder cancer in literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •All resectable Ca GB patients who have undergone R0 resection for Ca GB; Those who have not recieved neoadjuvant treatment; those who donot have stage IV disease.
排除标准
- •Metastatic disease; R1 resection for Ca GB; Stage IVb disease; Those who have recieved neoadjuvant treatment; Refused consent for adjuvant treatment.
结局指标
主要结局
Overall survival; Recurrence free survival
时间窗: 6 month; 1 year; 3 year; 5 year
次要结局
- Pattern of recurrence; Toxicity/Complication of chemotherapy and Chemoradiotherapy(in 30 days of completion of therapy;6month; 1 year; 3 year; 5 year.)