A randomized phase II trial comparing epirubicin, cisplatin, and capecitabine versus the combination of epirubicin, cisplatin, and capecitabine with pravastatin in patients with irresectable or metastatic gastric carcinoma.
Recruiting
- Conditions
- advanced irresectable or metastatic gastric carcinoma
- Registration Number
- NL-OMON27982
- Lead Sponsor
- ot applicable
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 43
Inclusion Criteria
Histologically proven, irresectable gastric adenocarcinoma, except carcinoma of the cardia, WHO 0-2, ability to swallow, adequate hepatic, renal and bone marrow function.
Exclusion Criteria
Prior chemotherapy or radiotherapy, current treatment with HMG-CoA-reductase inhibitor, peripheral neurotoxicity grade >2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival rate (PFR) after 6 months.
- Secondary Outcome Measures
Name Time Method Response rate scored according to the RECIST criteria, overall survival, quality of life, and toxicity graded according the international Common Toxicity Criteria”.