Randomized comparison of Sequential therapies with Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
- Conditions
- renal cell cancer
- Registration Number
- JPRN-UMIN000003040
- Lead Sponsor
- Yamagata University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 120
Not provided
1) History of any other malignancy 2) Central nervous system metastases. However, patients who remain asymptomatic, have no new or enlarging lesion in the CNS within 6 months of enrollment in this study, and require no corticosteroids may be enrolled. 3) History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment 4) History of cerebrovascular disorder including transient ischemic attack (TIA) 5) Pregnancy or possible pregnancy at any time during the study 6) Ongoing grade 2 adverse event prior treatment 7) Prior treatment with any anticancer therapy including cytokine therapy such as interferon-alpha and interleukin-2 8) Prior treatment with mTOR inhibitor 9) Prior treatment with sunitinib or sorafenib 10) Treatment with an test drug in a clinical research within 4 weeks of enrollment in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS in first-line treatment, Total progression free survival (PFS) in first-line and second-line treatments
- Secondary Outcome Measures
Name Time Method PFS in second-line treatment, Antitumor effect, survival, clinical benefit (CR+PR+NC), and adverse event