Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney - A Phase II study

The standard of care for fit patients with localised kidney cancer is surgical
resection of the kidney (nephrectomy). However, as renal cell carcinoma occurs
mostly in the elderly population, a significant portion of patients are not
able to tolerate surgery due to medical co-morbidities such as coronary heart
disease. In the modern era, effective local treatment of the renal primary may
become even more important as systemic targeted agents treatments improve and
prolong patient survival in the first line and second line settings. However,
in routine clinical practice many do not have surgery due to the associated
risks and morbidity. These patients represent a group in need of an effective
non-invasive alternative to surgery to control their kidney disease. Thus, an
alternative local treatment to nephrectomy can potentially benefit two groups
of patients: those who cannot be operated on due to medical co-morbidities; and
those patients with low volume metastatic disease where the morbidity of
non-curative surgical nephrectomy limits treatment to their primary. Definitive
external beam radiotherapy (EBRT) is often used to treat medically inoperable
patients with cancers in many different organs. However, renal cell carcinoma
(RCC) is conventionally considered *radioresistant* to fully fractionated EBRT.
Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive
method for precision irradiation of tumours using doses with a higher
biological effect than can be achieved with conventional radiotherapy.
Stereotactic radiotherapy is typically given as three or more fractions over a
period of one to two weeks.

The primary objective of this study is to estimate the efficacy of SABR for
primary RCC.

FASTRACK II is a single arm, multi-institutional phase II study. All
participants will receive SABR as definitive treatment for their primary renal
cell carcinoma.

- Radiation (in a schedule of 26 Gy in 1 fraction or 42Gy in 3 fractions);
- Questionnaires;
- CT's thorax/abdomen;
- Bloodwithdrawals;
- Split renal function study;
- Consultations.

SABR is very precise radiatoin, which will cause some burden. Most of the
investigations to monitor the patient will be done in standard practice. The
rest of the investigations are done to monitor the patient closely and measure
the effect of the treatment. Even though a certain burden and risk are part of
the trial, the treatment can have a positive effect on a better controle of the
tumor and thus on survival of the patient.