Randomized Parallel Group Phase II Clinical Study of Sorafenib/Interferon Combination Therapy and Sunitinib Monotherapy for Advanced Renal Cell Carcinoma
- Conditions
- Advanced renal cell carcinoma
- Registration Number
- JPRN-UMIN000001995
- Lead Sponsor
- Osaka Urological Oncology Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
1.Patients who have received systemic therapy for renal carcinoma 2.Patients who completed the surgery or radiotherapy for renal carcinoma less than 4 weeks before initiation of the present study 3.Patients suffering from multiple cancers within last 5 years, excepting those who received appropriate treatment for the following a. Basal cell carcinoma or squamous cell carcinoma of skin b. Uterine cervix carcinoma, gastric cancer or large intestine carcinoma (in situ) 4. Patients who are diagnosed as having cerebral metastasis, meningeal metastasis, spinal cord compression, or meningitis carcinomatosa 5. Patients who are found to have either of the following diseases within 12 months before initiation of the present study Myocardial infarction, severe or unstable angina, coronary or peripheral arterial bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism 6. Patients with arrhythmia (Grade 2 or severer according to the CTCAE ver. 3.0) or atrial fibrillation (regardless of Gragde), or male patients with QTc interval prolonged over 450 msec or female patients with QTc interval prolonged over 470 msec
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method