Trial comparing surgery first or chemotherapy first in stomach cancer
- Conditions
- Health Condition 1: null- Carcinoma stomach (gastric cancer)
- Registration Number
- CTRI/2013/05/003708
- Lead Sponsor
- South Indian Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 350
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method