Site and distribution of sentinel lymph nodes in renal cell carcinoma. A diagnostic study.
- Conditions
- kidney tumourrenal cell carcinoma1003836410038430
- Registration Number
- NL-OMON33464
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
1. Localized parenchymal tumor of the kidney not exceeding 10 cm (cT1-cT3)
2. No metastatic disease on imaging and clinical examination (cN0, cM0)
3. Age: 18 years and older
4. Life expectancy > 3 months
5. WHO performance status 0 or 1 and fit for surgery
6. Written informed consent obtained from the patient after having been informed about the objectives of the study and the medication used.
7. No prior systemic treatment with biological response modifiers, tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy.
1. Parenchymal kidney tumor larger than 10 cm
2. Clinically metastatic disease or at imaging
3. Patients in whom surgery is no option due to comorbidity
4. Current cardiovascular disease, hematopoetic, pulmonary, hepatic or renal dysfunction or WHO performance status > 1.
5. Previous immunotherapy, therapy with tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy.
6. Corticosteroid and/ or other immunosuppressive therapies.
7. Prior malignancies. In case of NED the period should be > 5 years.
8. Preganancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>*Main endpoint: Lymphatic drainage not localized locoregional<br /><br>retroperitoneally.</p><br>
- Secondary Outcome Measures
Name Time Method <p>*Secondary endpoints: Intra-operative mapping and detection, activation or<br /><br>downregulation of immune cells in sentinel nodes, cancer specific survival and<br /><br>morbidity, complication rate of surgery, sensitivity of the technique and stage<br /><br>migration.</p><br>