metastatic renal cell carcinoma and the primary tumor in situ
Conditions
Interventions
Trade Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic renal cell cancer of clear-cell subtype with a resectable asymptomatic primary in situ. Asymptomatic primary is defined as the absence of symptoms which can be exclusively assigned to the primary tumor such as flank pain and/or gross hematuria necessitating blood transfusion. As paraneoplastic symptoms cannot be assigned to the primary tumor alone in metastatic disease, they are not included in this definition. Unless the diagnosis of a clear-cell subtype has been established after histological examination of a resected metastatic lesion, all patients need to undergo a transcutaneous tru-cut needle biopsy of the primary tumor. 2. Extensive metastatic disease which is defined as 3 or more non-resectable metastases in case of 1 metastatic site, using the RECIST criteria, or 2 or more metastatic sites. 3. Age: 18 to 65 years 4. Life expectancy > 3 months 5. WHO performance status 0 or 1 6. Written informed consent obtained from the patient after having been informed about the objectives of the study and the medication used. 7. Blood counts: Leucocytes > 3.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 6.0 mmol/l. 8. Serum bilirubin, ASAT, ALAT and creatinin within 1.5 times of upper limit of reference values of laboratory. 9. No prior systemic treatment with biological response modifiers, tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy. Patients who receive local radiotherapy for bone lesions can be included. 10. An intermediate MSKCC risk profile 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. Symptomatic primary necessitating nephrectomy. For definition see Inclusion criteria. 2. Irresectable primary tumor 3. Patients in whom complete surgical remission can be achieved by removing metastatic sites at nephrectomy or by delayed surgery. 4. Previous nephrectomy 5. Low metastatic burden (2 or less non-resectable metastases at 1 metastatic site) 6. Metastatic RCC to the bone only. Bone metastases are considered truly non measurable. 7. Current cardiovascular disease, hematopoetic, pulmonary, hepatic or renal dysfunction or WHO performance status > 1. 8. Previous immunotherapy, therapy with tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy. 9. Presence of autoimmune disease, HIV and hepatitis. 10. Corticosteroid and/ or other immunosuppressive therapies. 11. Prior malignancies. In case of NED the period should be > 5 years. 12. Central nervous system metastases. 13. non-clear cell subtype. 14. Poor or good prognosis according to MSKCC risk assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the response rate of the primary tumor following pretreatment with sunitinib;Secondary Objective: Cancer specific survival and morbidity, overall response at metastatic sites and duration of metastatic response will be assessed. (Duration of overall survival; duration of hospital stay; percentage of withdrawal from nephrectomy due to sunitinib-related reduction of performance; response at metastatic sites; progression to irresectability of the primary tumor during initial treatment). Immunomonitoring in the peripheral blood at different time intervals and the primary tumor after nephrectomy. Imaging with CT and dynamic MRI scan prior to treatment with sunitinib and prior to nephrectomy to identify potential response criteria other than RECIST in association with histopathology. ;Primary end point(s): The main end point of this study is any objective response in the primary tumor according to RECIST criteria . | — |
Countries
Netherlands
Outcome results
None listed