Early Findings of a Prospective Clinical Trial of Stereotactic Ablative Body Radiotherapy for Primary Renal Cell Carcinoma — YRD
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Early Findings of a Prospective Clinical Trial of Stereotactic Ablative Body Radiotherapy for Primary Renal Cell Carcinoma (#123)

S Siva 1 2 , D Pham 1 , T Kron 1 2 , T Devereux 1 , N Corcoran 2 , M Bressel 1 , N Brook 3 4 , R Grills 5 , F Foroudi 1
  1. Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia
  2. University of Melbourne, Parkville, VIC
  3. Royal Adelaide Hospital, Adelaide, SA
  4. University of Adelaide, Adelaide, SA
  5. Barwon Health, Geelong Hospital, Geelong, VIC

Background/significance:

Stereotactic Ablative Body Radiosurgery (SABR) is a novel, non-invasive and potentially curative treatment for medically inoperable patients.

Objectives:

This is an interim report of the first Australian prospective study of SABR in primary RCC, specifically addressing feasibility and tolerability of the technique.

Methods:

The FASTRACK trial is a prospective single arm pilot study. Eligible patients were either medically inoperable, technically high risk or refused surgery. Investigations included serum creatinine and eGFR, 4DCT planning, diffusion/perfusion MRI and SPECT/CT or PET-GFR split differential renal scans. When possible, histopathological confirmation was mandated. Patients with tumours ≤ 5cm were given 26Gy in a single fraction of radiosurgery, whilst patients with tumours > 5cm were given 42Gy in 3 fractions. 

Results:

From June 2012 to December 2012, 12 patients with primary RCC were enrolled with a further 8 patients screened. The median follow-up was 6 months. There were 9 males and 3 females, with the median age being 76 years. The mean (range) of maximal tumour dimension was 51mm (20mm-75mm), with 2 patients having T1a disease, 7 patients with T1b disease, and 2 patients with T2 or T3 disease. Histopathological confirmation occurred in 9/12 cases, with 2 of the remaining 3 having demonstrated both serial growth and radiological features consistent with RCC. The median (range) pre-treatment creatinine was 106mol/L (72-272mol/L). All patients completed the prescribed treatment. The most common treatment related toxicity was transient fatigue. Three patients were completely asymptomatic from treatment. No patient suffered a toxicity requiring hospitalization (or grade 3+ toxicity). There has been no significant impact on renal function calculated from SPECT/CT GFR (p=0.57) to date.

Conclusion:

SABR for primary renal cell carcinoma to date appears highly tolerable and feasible. The ongoing FASTRACK clinical trial will establish the efficacy and toxicity profile of this treatment in the Australian setting.