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临床试验/CTRI/2011/12/002264
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

All India Institute of Medical Sciences0 个研究点目标入组 16 人开始时间: 待定最近更新:

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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