Efficacy and Safety of Cytokines Versus Sunitinib as First-line Followed by Second-line Axitinib in the Treatment of Patients with Metastatic Renal Cell Carcinoma: A Phase III Randomized Sequential Open-Label Study
Phase 3
- Conditions
- metastatic renal cell carcinoma
- Registration Number
- JPRN-UMIN000012522
- Lead Sponsor
- Innovative Clinical Research Center, Kanazawa University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with history of hypersensitivity against IFN, IL-2, Sunitinib, or Axitinib 2. Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby (including men) 3. Patients with a history of hypersensitivity to biological preparations such as vaccines 4. Patients having Shou-Sai-Kotou (special herbal drug) 5. Patients with autoimmune hepatitis 6. Patients with a history of interstitial pneumonia 7. Patients treated for another primary malignancy within 3 years of enrollment 8. Patients judged ineligible to participate in the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of cytokines followed by axitinib is superior compared to sunitinib followed by axitinib.
- Secondary Outcome Measures
Name Time Method 1. Overall survival (OS), descriptively in each arm 2. PFS in 1st-line and 2nd-line treatment, descriptively in each arm 3. Objective response rate (ORR) and disease control rate (DCR) in 1st-line and 2nd-line treatment, descriptively in each arm 4. Time to treatment failure (TTF) in 1st-line treatment, descriptively in each arm 5. Total TTF from 1st-line to 2nd-line treatment, descriptively in each arm 6. Safety 1st-line treatment, descriptively in each arm 7. Health-related Quality-of-life (HRQOL) in 1st-line and 2nd-line treatment, descriptively in each arm 3. PFS, ORR, and DCR in in 3rd-line and 4th-line treatment, descriptively in each arm