Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)

This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.

Who is it for?

• Age > 18 years old
• All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
• ECOGperformance of 0-2 inclusive.
• Life expectancy > 9 months
• Either medically inoperable, technically high risk for surgery or decline surgery.
• Multidisciplinary decision for active treatment

Study Details:

Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. This study will be evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of cancers of the kidney.

Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only).

All participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.

The follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).

Inclusion Criteria:

• Age > 18 years old
• All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
• Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive.
• Life expectancy > 9 months
• Either medically inoperable, technically high risk for surgery or decline surgery.
• Multidisciplinary decision for active treatment

Exclusion Criteria:

• Pre-treatment estimated glomerular filtration rate < 30 mls/min
• Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
• Previous high-dose radiotherapy to an overlapping region
• Tumours of larger than 8cm is size