Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
Every year, 12500 primary renal cell carcinoma (RCC) are diagnosed in France. Metastases
occur in half of RCC patients.
Management of metastatic RCC is based on systemic treatments (targeted
therapies/immunotherapy). However, resistance to systemic treatment is frequent. In case of
progression, usual therapeutic attitude is initiating another systemic therapy.
Because of the emergence of resistant tumor clonal cells, some patients progress only on few
sites while the rest of tumor burden is controlled. In this setting named oligoprogressive
disease [isolated progression of <3-5 metastase(s)], ablative treatments of these evolving
metastatic sites could allow a disease control and a reduced risk of new metastases
occurrence by tumor-cell reembolization. Such strategy is challenging to prolong ongoing
systemic treatment and delay further lines.
Although RCC was considered radioresistant and radiotherapy with conventional fractionation
was mainly used for palliation of symptoms, stereotactic radiotherapy (SRT), by delivering
high dose in one or few fractions, allows local control for about 90% of RCC metastases
through various radiobiological pathways. Furthermore, some data suggest that high-dose focal
irradiation of RCC could induce a systemic antitumor response mediated by immunologic
effectors(1). This phenomenon ("abscopal effect") could be enhanced in patients under
immunotherapy, including anti-PD1.
Several retrospective studies and one non-randomized phase-II study highly suggest the
interest of SRT as focal ablative treatment in RCC oligometastases with excellent local
control rates and low toxicity(2,3).
Furthermore, the multicentric retrospective study the sponsor recently conducted within the
GETUG group among 101 metastatic RCC patients with oligoprogression under systemic therapy
highlighted that SRT on progressive sites provided a median of 8.6-month progression-free
survival and allowed to continue current systemic line for 10.5 months.
However, to date, there are no prospective data assessing the interest of SRT for management
of oligoprogressive metastatic RCC.
The sponsor aim to prospectively evaluate the interest of SRT as a therapeutic strategy for
local control of oligoprogressive metastatic RCC under ongoing systemic treatment, and
consequently delay subsequent systemic treatment.