A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial)
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000013783
- Lead Sponsor
- Gunma Oncology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1.Need to drain malignant celomic fluid. 2.Multiple primary cancers within 5 years. 3.With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium. 4.With a history of adverse events related to DPD loss. 5.Evidence of interstinal lung disease, or pulmonary fibrosis. 6.Uncontrolled infection. 7.Difficult for oral intake. 8.Radiological evidence of CNS metastases or brain cancer. 9.Complication of cerebrovascular disease or symptoms within 1 year. 10.Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 11.The patient who is planning the surgical treatment during trial. 12.Administering antithrombotic drug within 10 days. 13.Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). 14.Evidence of bleeding diathesis or coagulopathy. 15.Uncontrollable ulcer indigestive tract. 16.Renal failure to be treated, 3+ or higher proteinuria within 2 weeks prior to entry. 17.Uncontrolled Hypertension. 18.Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. 19.Pregnant or lactating women or women of childbearing potential. 20.Other conditions not suitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival Overall Response Rate Duration of response Disease Control Rate Duration of response during maintenance phase Safety Quality of Life