Health Condition 1: null- Carcinoma stomach (gastric cancer)
Conditions
Interventions
Intervention1: Perioperative chemotherapy: 2 cycles of chemotherapy is given initially followed by surgery and then 4 more cycles of chemotherapy is given after completion of surgery
Control Intervent
Sponsors
South Indian Oncology Group
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare overall survival and disease free survival in patients with locally advanced resectable gastric cancer treated with either perioperative or only postoperative chemotherapyTimepoint: Overall and disease-free survival will be analysed at 3 years and 5 years after completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate toxicity of and disease response to neoadjuvant chemotherapy 2. Evaluate the postoperative complications following neoadjuvant chemotherapy 3. Compare the curative resection rates in patients treated with these regimens. 4. Evaluate and compare quality of life in these patients before and after surgery 5. Include molecular/ biomarkers to assess response to neoadjuvant therapy Timepoint: Post-treatment | — |
Countries
India
Contacts
Public ContactDr Ramakrishnan A S
Cancer Institute (WIA)
Outcome results
None listed