CTRI/2011/12/002264已完成2 期
Concurrent versus sequential neoadjuvant chemo-radiotherapy followed by surgery in operable carcinoma gallbladder patients: A pilot study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a) Subjects with FNAC-proven Gall bladder adenocarcinoma (up to operable stage IVA) which is potentially resectable by preoperative imaging
- •b) Performance status ECOG-1&2
- •c) Normal renal, hepatic, and hematologic function at the time of enrolment
- •d) Age 18-65 years
排除标准
- •a) Patient refusal
- •b) Poor performance status (ECOG â?? 3&4)
- •c) Major co-morbid conditions like cirrhosis, renal failure, uncontrolled hypertension or cardiac failure -
- •d) Subjects who have received chemotherapy within 12 months prior to study entry.
- •e) Prior use of radiotherapy.
- •f) Subjects who have undergone previous surgery on gall bladder/biliary tree.
- •g) Any evidence of metastasis to distant organs (liver, lung, peritoneum).
- •h) Non-contiguous liver metastasis (M1 disease).
- •i) Major vascular involvement such as proper hepatic artery involvement and main portal vein involvement (T4 â?? inoperable disease).
- •j) Periaortic, Pericaval, Superior mesenteric artery and/or Celiac artery lymph node involvement (N2 disease) â?? confirmed by FNAC.
研究者
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