A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases (FASTRACK)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases|
- The number of patients who complete prescribed treatment. [ Time Frame: After 24 months ] [ Designated as safety issue: No ]This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)
- Toxicity of SBRT in study patients measured using CTCAE V4.0 [ Time Frame: Between 2-4 weeks after radiotherapy and 3 monthly for 12 months ] [ Designated as safety issue: Yes ]
Specific toxicities will include, but are not limited to;
- Gastrointestinal (Nausea, vomiting, diarrhoea, acute ulceration)
- Pulmonary (atelectasis, cough, dyspnoea, hypoxia, pleural effusion, fibrosis)
- Skin/chest wall (radiation dermatitis, rib fracture)
- Kidney (acute renal dysfunction) Freedom from severe toxicity will be reported asn defined as: time from treatment delivery until first recorded grade 4, or 5 toxicity as measured by CTCAE V4.0.
- Efficacy of stereotactic radiosurgery [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]Effective SBRT is defined as a treatment which results in local control at 1 year after treatment. Local control is defined as lack of progression of the target lesion as measured by RECIST criteria. RECIST criteria are a CT evaluation of change in tumour size.
- Feasibility of using Diffusion weighted-MRI for response assessment. [ Time Frame: At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days) ] [ Designated as safety issue: No ]Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size.
For lesions <5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.
The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size.
For lesions <5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676428
|Peter MacCallum Cancer Centre|
|East Melbourne, Victoria, Australia, 3002|
|Principal Investigator:||Shankar Siva||Peter MacCallum Cancer Centre, Australia|