unresectable/advanced gastric cancer
Conditions
Interventions
It takes three weeks for a one course of oxaliplatin plus capecitabin combination therapy (XELOX). Patients undergo this treatment until progression or severe AE.
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically proven gastric carcinoma or adenocarcinoma on the esophago-gastric junction 2)resistant /intolerable to fluoropyrimydine, CDDP, CPT-11 or Taxane 3)age over than 20 years old 4)Performance Status by Eastern Cooperative Oncology Group of 0,1 or 2. 5)with measurable lesions (RESIST ver. 1.1) 6)Patients who can take food orally 7)expected survival period longer than 3 months 8)with a rest longer than 14 days after the end of prior therapy 9) with good functions of important organs 1. Neutrophil: =>1,500/mm3 2. Hemoglobin: =>8.0 g/dl without blood transfusion within 14 days 3. Platelet: =>100,000/mm3 4. AST, ALT: =< 100 IU/L 5. T.bil.: =<1.5 mg/dL 6. s-cleatinine: =<1.2mg/dL 10) with a peripheral neuropathy lower than Grade 1 11) with written Informed Consent
Exclusion criteria
Exclusion criteria: 1)With prior chemotherapy including oxaliplatin (L-OHP) 2)With some active double cancers 3)With severe complications 4)With active infectious diseases which need treatments 5)With thoracic fluid and/or ascites which need drainage 6)under continuous steroids medication 7)under medication of phenytoin and/or warfarin 8)with active bleeding which needs frequent blood transfusion 9)with central nerve metastases with symptoms 10) with psychological disorders 11) Pregnant and/or nursing women or men who like to have children 12)Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Progression Free Survival, Time To Failure, Response Rate, Incidence of Adverse Events | — |
Countries
Japan
Contacts
Public ContactNaotosi Sugimoto
Osaka International Cancer Institute Department of medical oncology
Outcome results
None listed