CTRI/2013/05/003708RecruitingPhase 3
Randomized controlled trial of perioperative versus postoperative chemotherapy in resectable carcinoma stomach - SIOG-STO-1
South Indian Oncology Group0 sites350 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 350
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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