Patients with metastatic Renal Cell Carcinoma not previously treated with nephrectomy and systemic therapy. MedDRA version: 9.1 Level: LLT Classification code 10050018 Term: Renal cancer metastatic
Conditions
Interventions
Trade Name: SUTENT*30CPS 50MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB MALEATO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
CONSORZIO ONCOTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Metastatic RCC proven 2. Measurable disease (RECIST criteria) 3. Eligible for cytoreductive nephrectomy ? The primary tumor is considered amenable to surgical extirpation by the attending surgeon. Patients with thrombosis of the inferior vena cava below the epathic veins are not excluded. 4. No prior systemic therapy for RCC 5. Age 18 6. ECOG Performance Status 0-1 7. Adequate hematology, coagulation, hepatic, amilase and lipase, renal and cardiac function 8. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior systemic therapy for RCC (chemotherapy, hormonal therapy, interferon, interleukin-2, lymphocyte-activated killer cells or other biologicresponse modifiers) 1. Patients who required early nephrectomy because of clinical condition 2. Presence of symptomatic brain metastases 3. History of uncontrolled hypertension and/or clinically significant cardiovascular events or disease during the preceding 12 months 4. Previously history of cancer unless they are free of disease for at least five years or unless their cancer was adequately treated basal-cell skin cancer, squamous-cell skin cancer or in situ cervical cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: to and to compare to standard - activity (Response Rate) - safety;Secondary Objective: Secondary objectives: to - TTP (Time To Progression) - Duration of Response - OS (Overall Survival);Primary end point(s): N.D. | — |
Countries
Italy
Outcome results
None listed