Ablative tReatment of inoperable REnal cell carcinoma using STereotactic body Radiotherapy
- Conditions
- kidney cancerRenal cell carcinoma100383641003843010038365
- Registration Number
- NL-OMON46152
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- Inoperability, or when a patient refuses surgery (i.e. not eligible for (partial-) nephrectomy or RFA);
- Kidney function allows for intervention, as evaluated by treating urologist (taking into account eGFR and renogram);
- Age * 18 years;
- Written informed consent;
- Diagnosis of RCC confirmed by pathology (in case determined after informed consent, patients who are not eligible anymore (no RCC) will be excluded).
- Evidence of metastatic disease;
- Exclusion criteria for contrast enhanced MRI scan, according to the protocol of the department of Radiology, UMC Utrecht;
- Patients with one functioning kidney;
- Prior renal surgery (partial nephrectomy);
- Prior radiotherapy on upper abdomen;
- Unsafe to have fiducial marker implantation: i.e. anticoagulant agents use other than acetylsalicyl acid, which cannot be safely stopped/bridged for implantation;
- WHO * 3;
- Chemotherapy < 3 weeks before treatment;
- Targeted therapy (sunitinib etc) * 7 days before treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Newly developed acute toxicity grade 3 or more according to the Common<br /><br>Terminology Criteria for Adverse Events (CTC-AE) version 4.0.<br /><br>The treatment is considered successful if all 5 treatments are completed and if<br /><br>in total <15% of the patients (=5 patients) report a toxicity * grade 3.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be treatment response, (late) toxicity assessment,<br /><br>local control rate and quality of life assessment.</p><br>