Randomized controlled trial of perioperative versus postoperative chemotherapy in resectable carcinoma stomach - SIOG-STO-1

South Indian Oncology Group0 个研究点目标入组 350 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Histologically proven adenocarcinoma of the stomach or Siewert type 3 adenocarcinoma of the gastroesophageal junction stage T2-4 Nx or Tx N+.
•Resectable disease
•No distant metastasis, including peritoneal carcinomatosis
•No gastric outlet obstruction or uncontrolled bleeding
•CT scan and diagnostic laparoscopy are mandatory
•No prior therapy for the diagnosed gastric cancer
•Patient characteristics:
•Age- 20 to 69 years
•ECOG performance status 0-2
•Hemopoetic-
•WBC > 4000/ cu. mm
•Absolute neutrophil count > 2000/cu.mm
•Platelet count > 100,000/ cu.mm
•Hepatic- bilirubin not more than 1.5 times upper limit of nomal, AST & ALT not more than 1.5 times upper limit of normal
•Renal- Creatinine not more than 1.25 times ULN, creatinine clearance > 60 ml/min
•Cardiovascular-no prior arrhythmias, no prior congestive cardiac failure, no myocardial infarction within past 6 months, no unstable cardiac disease requiring treatment, Ejection fraction >50% on echo
•Pulmonary- no evidence of severe obstructive or restrictive airway disease on pulmonary function tests.

•Not pregnant or nursing
•Fertile patients must use effective contraception
•No other prior or concurrent neoplasm except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin
•No active infection
•No allergy to protocol drugs
•No history of significant neurologic or psychiatric disorders
•No other serious medical condition that would prevent compliance

发起方

South Indian Oncology Group