Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: CAPOX/mFOLFOX-7): Arm 1
3 weekly Oxaliplatin (130 mg m-2 iv on day 1 q 3 weekly) plus Capecitabine (2000â??mgâ??mâ??2, P.O, on days 1â??14 q 21 days)
OR
2 weekly Oxaliplatin (85 mg m-
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1) 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 , 2) ECOG performance status 0 to 2 3) Patient who can give informed consent for the study. 4) Patient does not have any contraindications to receive chemotherapy 5) Adequate hematological, hepatic and renal function parameters 6) Normal cardiac ejection fraction, as assessed by echocardiography 7) 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. 8) Written patient consent form
Exclusion criteria
Exclusion criteria: 1) Patient having Her 2 positivity and planned for her2 directed therapy in combination with chemotherapy 2) Known hypersensitivity against, 5-FU, capecitabine, leucovorin, oxaliplatin or docetaxel 3) Known contraindications against 5-FU, leucovorin, capecitabine, oxaliplatin, or docetaxel 4)Previous history of treatment with docetaxel, 5 FU, oxaliplatin, or capecitabine 5)Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV 6) Clinically significant valvular defect 7)Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix 8) Known brain metastases 9)Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy 10) Other severe internal disease or acute infection 11)Baseline neuropathy > NCI Grade I 12)Chronic inflammatory bowel disease 13) On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study 14) Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II To evaluate safety and adverse event profile of triplet and doublet regimens in advanced gastric cancers Phase III To evaluate difference in overall survival between two potential standards of care Timepoint: 54 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Progression free survival 2) Comparison of toxicity between 2 arms 3) Event free survival (EFS) 4) Progression free survival (PFS) 5) Response rates 6) Quality of life 7) Time to deterioration of ECOG PS Timepoint: 54 month | — |
Countries
India
Contacts
Public ContactAnant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed