None listed
Conditions
Interventions
Group 1 Type of group
1. Induction treatment: Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous
Two weeks without treatment
Repeat the course once.
2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
3. Randomization
4. Surgery.
5. P
Day 3: Cisplatin 60 mg/m^2, IP
2 weeks without treatment
Group 2 Type of group
Repeat the course once. 2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease. 3. Randomization 4. Surgery.
6. Postoperat
Sponsors
New York University School of Medicina,
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Only untreated patients with histologically documented gastric/GEJ adenocarcinoma, clinical American Joint Committee on Cancer (AJCC) stage grouping (11) IB-IV (Mo) by CT scan and laparoscopy/endoscopic ultrasound, are eligible. Excluded are patients in need of urgent surgery for gastro-intestinal obstruction, perforation or hemorrhage. • Both men and women >= 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status 0-2, members of any ethnic group and minorities. • Since immune deficiency increases the risk of terminal infections when aggravated by bone marrow suppressive therapy, patients must be without active or uncontrolled infection including HIV. • Patients without psychiatric disorders that may interfere with their consent and/or with protocol follow-up. • An adequate bone-marrow reserve (absolute neutrophil count >= 1,500/ mmL, thrombocytes >= 100,000 mmL, hemoglobin >= 9 gm/dL). • Preserved liver and renal function (total serum bilirubin = 50 mL/min) are required. Creatinine clearance should be normalized for 1.73 M^2 BSA. The prothrombin time, activated partial thromboplastin time, and thrombin time should be within the range of normal values. • Since chemotherapeutic agents to be used are known or suspected to be teratogenic or with other adverse effects, women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. All patients of reproductive age may not participate unless they agree to use an effective medically acceptable contraceptive method. • Patients who signed written informed consent.
Exclusion criteria
Exclusion criteria: • Patients with another invasive malignancy, with adequately treated basal cell or squamous cell skin cancer, free for 5 years or more of in-situ cervix cancer or other in-situ cancer. • Patients with diagnosed Gilbert´s disease and bilirubin level >= 2.0 mg/dL, as these patients may have excessive CPT-11 toxicity. • Prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. Capecitabine (Xeloda) is contraindicated in patients with severe renal impairment, i.e., creatinine clearance below 30 mL/min, determined by Cockcroft-Gault equation shown on page 15 under (i) Renal impairment. In patients with moderate renal impairment (creatinine clearance 30-50 mL/min), which develops during the course of adjuvant treatment with Capecitabine, the drug is decreased to 75% of the starting dose. • Any severe concurrent disease, such as cardiac condition not responding to medication, myocardial infarction within the last 12 months, active infection or uncontrolled pulmonary disease, or any other disease which in judgment of the investigator would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy. Measure:Number of Patients With One-year Recurrence-free Survival Timepoints:1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:This is defined as the patients who did not have recurrence of cancer since the start of induction chemotherapy. Measure:Overall Survival Rate Timepoints:every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years ; Outcome name:Emergence of adverse events Measure:Toxicity Timepoints:every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years | — |
Countries
Peru, United States
Outcome results
None listed