Carcinoma, Renal Cell
Conditions
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.
Interventions
RADIATIONStereotactic body radiotherapy
A first line TKI will be administered according to the standard dosing of the drug for metastatic RCC during a 1-week run-in period after which SBRT will be delivered to the largest metastatic lesion concurrently with the TKI. The SBRT dose will be escalated in 3 dose levels, starting at 24Gy (8 Gy per fraction), followed by 30 Gy (10 Gy per fraction) and 36 Gy (12 Gy per fraction).
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* prior systemic treatment for RCC * uncontrolled central nervous metastases * prior radiotherapy interfering with SBRT * any disorder precluding understanding of trial information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 4 years | Response rate will be evaluated at 12 weeks following the start of TKI. |
| Immunomonitoring | 4 years | Immunomonitoring before start of TKI, before SBRT and 2 weeks after SBRT. |
Countries
Belgium
Outcome results
None listed