unresectable or recurrent gastric cancer
Conditions
Interventions
Sponsors
Tohoku Clinical Oncology Research and Education Society (T-CORE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are required to fulfill the following criteria for eligibility. 1) histologically confirmed as adenocarcinoma of the stomach 2) One or more evaluable lesions confirmed by CT or other imaging within 28 days before the registration. 3) ECOG performace status: 0-2. 4) Received only one previous chemotherapeutic regimen which is 5-FU-based (inluding patients who had recurrence during or within 24 weeks after adjuvant chemotherapy) 5) Estimated to survive for three months or more since registration. 6) Written informed consent. 7) Age 70 or above. 8) Fulfill the following hematological and biochemical data obtained in the most recent blood and urine tests. Neutrophils >= 1,500 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 8.0 g/dl, AST =< 100 IU/l, ALT =< 100 IU/l, total bilirubin =< 1.5 g/dl, and creatinie =< 1.5 in blood test, and urine protein <= 1+ or 2 g/day. Patients should not receive transfusion or granulocyte colony stimulating factor within 14 days before the blood test. 9) Determined to be able to receive the study protocol by the responsible researcher or contributing researchers of this study.
Exclusion criteria
Exclusion criteria: Patients who fulfill the following criteria for exclusion are excluded. 1) Received taxane-based regimen. 2) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer. 3) Active infection and inflammation. 4) Active hepatitis. 5) Current or past history within 1 year of serious heart disease that requires hospitalization 6) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis. 7) Active gastrointestinal bleeding. 8) Gastrointestinal perforation or histula, artelial embolism within 6 months or venous thromboembolism within 3 months before registration. 9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs. 10) Grade 2 or more neuropathy. 11) Effusion that requires drainage. 12) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Tissue biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from ramucirumab plus paclitaxel therapy 2.Serum biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from ramucirumab plus paclitaxel therapy 3.SNPs that correlate with toxicities from ramucirumab plus paclitaxel therapy | — |
Countries
Japan
Contacts
Public ContactHideki Shimodaira
Tohoku Clinical Oncology Research and Education Society (T-CORE) Administration Office
Outcome results
None listed