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Clinical Trials/CTRI/2013/05/003708
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

Sponsor
South Indian Oncology Group

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