Health Condition 1: null- advanced stomach cancer patients able to take tablets orally with normal organ function and a good performance status Health Condition 2: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: EOX plus Aspirin: patients of locally advanced and metastatic gastric cancer fulfilling the inclusion criteria
Control Intervention1: EOX: patients of locally advanced and metastatic ga
Sponsors
Jawaharlal Institute of Post graduate Medical education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Locally advanced and metastatic gastric cancer patients 2. Performance status 3. Able to take oral medications 4. normal platelet counts
Exclusion criteria
Exclusion criteria: 1. Significant organ dysfunction such as a.cardiac EF 2mg/dl, c. Altered liver function-serum bilirubin >1.5mg/dl, AST/ALT >3xULN, ALP >5xULN 2. previously on any dose of Aspirin 3. Aspirin hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate PFS OS toxicitiesTimepoint: OS is defined as the time from entry into the clinical trial until death as a result of any cause.PFS is the time from entry into the study until progression or death as a result of any cause.recruitment started from March 2017 and will stop in June 2018.Response assessment will be done every 3 to 4 chemotherapy cycles by imaging and at every cycle clinically. After completion of chemotherapy imaging will be done every 3 months.based on the RECIST 1.1 CR/PR/SD/PD and PFS will be defined. | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate PFS OS with respect to PI3K expressionTimepoint: Overall survival- Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause. PFS- PFS is defined as the time from entry onto a study until disease progression or death as a result of any cause. | — |
Countries
India
Contacts
Public ContactESHA JAFA
JIPMER
Outcome results
None listed