Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: Resveratrol: Chemotherapy regimen given will be DCFDocetaxel 50 mg /m2 iv on D1 (i.v. over 1 hour),
Cisplatin 60 mg/m2 iv on D1 (i.v. over 1 to 3 hours),
5-Fluorouracil 200mg/m2/day by
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed adenocarcinoma of the gastroesophageal junction or the stomach (any T, any N category, M1), or (any T, any N category, M0), but unresectable disease, with the following specifications Radiological evidence of metastatic disease or and unresectable local disease as assessed by surgical oncologist -ECOG performance status 0 to 2 -Patient who can give informed consent for the study -Patient does not have any contraindications to receive chemotherapy -Adequate Hematological, hepatic and renal function parameters -Renal function Creatinine less than or equal to 1.5 ULN, Creatinine clearance more than or equal to40 mL per min. -Normal cardiac ejection fraction as assessed by echocardiography -Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial. -patient given informed consent form
Exclusion criteria
Exclusion criteria: Patients with Her2 positive metastatic adenocarcinoma planned for her2 directed therapy in addition to chemotherapy as first line regimen -Known hypersensitivity against cisplatin, 5-FU, capecitabine, leucovorin, oxaliplatin or docetaxel Known contraindications against 5-FU, leucovorin, capecitabine, oxaliplatin, or docetaxel Previous history of treatment with docetaxel, 5 FU, oxaliplatin, or capecitabine Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV, -Clinically significant valvular defect -Past or current history of other malignancies except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix -Known brain metastases -Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy -Other severe internal disease or acute infection -Baseline neuropathy > NCI Grade I -Chronic inflammatory bowel disease -On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study -Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in chemotherapy toxicity (grade 3 or grade 4)Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall survivalTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactVikas Ostwal
Tata Memorial Hospital
Outcome results
None listed