Addition of resveratrol copper with chemotherapy in gastric cancer patients
- Conditions
- Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
- Registration Number
- CTRI/2019/07/020289
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in chemotherapy toxicity (grade 3 or grade 4)Timepoint: 3 years
- Secondary Outcome Measures
Name Time Method Progression free survival <br/ ><br>Overall survivalTimepoint: 3 years