Cancer Clinical Trial
Official title:
A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases
This is a "proof of concept" study, to assess the feasibility of introducing a novel high-precision radiotherapy technique called "stereotactic radiosurgery" (SRS) or "stereotactic body radiotherapy" (SBRT) for the treatment of kidney cancers in Australia. This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated adrenal metastases from non-small cell carcinoma who are either medically inoperable, high risk for surgery, or decline surgery to participate. In cohort of patients with renal cell carcinoma, both patients with primary disease only, and those patients who have limited metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment, this study will be to assess efficacy, toxicity and tumour response using a novel imaging biomarker called diffusion weighted-MRI.
FASTRACK is a 2 -cohort, non-randomised prospective feasibility study. Anticipated total
duration of accrual is approximately 24 months, with all patients expected to complete all
protocol treatment and imaging within a further 3 months. The trial will close after the
last patient has completed his/her last protocol related follow-up visit (at 12 months
post-treatment).
Cohort 1: patients with renal cell carcinoma within the kidney Cohort 2: patients with
solitary adrenal metastases from non-small cell lung carcinoma The investigational treatment
will be prescribed the covering isodose, ensuring that 99% of the PTV is covered by 100% of
the dose (D99=100%). It is anticipated that most treatments should be highly conformal.
Treatment must be delivered with at least six (6) non-opposing conformal megavoltage photon
beams. It is anticipated that a typical range of beam numbers would be 8 to 12, comprising
of at least 6 co-planar beams and 1-2 non-coplanar beams. No cytotoxic chemotherapy is
allowed within 3 weeks or concurrently with respect to the investigational treatment.
Consultation with the treating radiation oncologist is strongly recommended if chemotherapy
is to be considered after the investigational treatment and before documented disease
progression, to prevent unforeseen combined toxicities. Targeted agents (such as sunitinib)
are exempt from this recommendation.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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