Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma
- Conditions
- Advanced Renal Cell Carcinoma
- Registration Number
- JPRN-UMIN000001994
- 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
- 100
Not provided
1.Patients who have had systemic treatment for renal cancer 2.Patients for whom the period after a surgery or the end of radiotherapy is less than 4 weeks at the start of protocol treatment 3.Patients suffering double carcinoma within 5 years. However, the following patients who received appropriate treatment are acceptable as the subjects. a. Basal cell carcinoma of the skin or squamous cell cancer b. Cervical cancer, stomach cancer, or colon cancer (in situ) 4.Patients diagnosed as brain metastasis, spinal cord compression, or meningitis carcinomatosa 5.Patients showing either of the following within 12 months before the start of protocol treatment: Myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral bypass graft, symptomatic congestive heart failure, cerebrovascular attack or transient ischemic attack, or pulmonary embolism 6.Patients with arrhythmia or atrial fibrillation (any grade) by CTCAE Ver. 3.0, or QTc interval prolongation at >450 msec in men and >470 msec in women 7.Patients with uncontrollable hypertension (>150/100 mmHg in spite of the most proper medication) 8.Patients administered warfarin continuously (oral administration of a low dose of warfarin up to 2 mg/day is acceptable) 9.Patients for whom human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases or hepatitis B or C virus are confirmed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method