Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect.
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Radiation: Stereotactic body radiotherapy
- Registration Number
- NCT02334709
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Tyrosine kinase inhibitors (TKIs) are often used in the standard treatment for patients with metastasized renal cell carcinoma. In addition to their ability to specifically inhibit tumor growth, TKIs also interfere with the vascularisation of the tumor. Unfortunately, most patients do not obtain long-lasting clinical benefit from this treatment. The goal of the current study is to enhance the effect of TKIs by combining them with stereotactic radiotherapy treatment of one of the metastases. This type of radiotherapy allows us to precisely irradiate the tumor with minimal effect on the surrounding healthy tissue. Recently it has been demonstrated that this type of radiotherapy stimulates the immune system to attack the tumor. By combining stereotactic radiotherapy with TKIs we expect to observe a reduction of metastases in a bigger population of patients.
In the first part of our study we focus on the safety of the combination therapy. In the second part we will evaluate the combined treatment response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- signed informed consent
- diagnosis of RCC with clear-cell component histology
- at least 3 extracranial measurable metastatic lesions per RECIST
- Karnofsky Performance score >60
- patients should have undergone cytoreductive treatment of their RCC at least 6 weeks prior to inclusion
- patients should have adequate organ function for TKI treatment.
- prior systemic treatment for RCC
- uncontrolled central nervous metastases
- prior radiotherapy interfering with SBRT
- any disorder precluding understanding of trial information.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SBRT + fixed dose Tyrosine Kinase Inhibitor Stereotactic body radiotherapy Single arm phase I trial with 3 dose-escalation arms
- Primary Outcome Measures
Name Time Method Dose limiting toxicity 2 years Dose limiting toxicity will be assessed before start of TKI, before SBRT, at the end of SBRT and at each follow-up visit
- Secondary Outcome Measures
Name Time Method Immunomonitoring 4 years Immunomonitoring before start of TKI, before SBRT and 2 weeks after SBRT.
Response rate 4 years Response rate will be evaluated at 12 weeks following the start of TKI.
Trial Locations
- Locations (1)
Dept. of Radiotherapy, Ghent University Hospital
🇧🇪Ghent, Oost-Vlaanderen, Belgium