metastatic renal cell carcinoma
Conditions
Interventions
Cytokines (IL-2+ IFN) as 1st-line followed by 2nd-line Axitinib
Sunitinib as 1st-line followed by 2nd-line Axitinib
Sponsors
Innovative Clinical Research Center, Kanazawa University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have already performed nephrectomy with metastatic renal cell carcinoma (RCC) 2. Patients with confirmed clear cell RCC 3. Patients who had not received any prior systemic treatment for metastatic RCC 4. Patients with the Memorial Sloan-Kettering Cancer Center (MSKCC) risk criteria of favorable or intermediate 5. Patients who have at least one measurable lesion on CT or MRI at baseline as per the RECIST 1.1 criteria 6. Age: 20-80 years old, both inclusive 7. Patients with ECOG performance status of 0 or 1 8. Patients with sufficient hematopoietic function who meet the following all criteria - Neutrophil >= 1,500/mm3 - Platelet >= 10 times 104/mm3 - Hemoglobin > 9.0 g/dL 9. Patients with sufficient hepatic functions who meet the following all criteria - Total-bilirubin <= 1.5 times ULN - AST and ALT <= 2.5 times ULN (patients with hepatic metastasis <= 5.0 times ULN) 10. Patients with sufficient renal function who meet the following criterion Serum creatinine <= 2.0 times ULN 11. Patients who are expected to have more than 3 months of life expectancy 12. Patients who gave informed consent for participation to the study after they received explanation of the briefing document
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroyuki Konaka
Kanazawa University Hospital Urology
Outcome results
None listed