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:||April 2015|
|Estimated Primary Completion Date:||February 2014 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676428
|Contact: Shankar Siva||+61 3 firstname.lastname@example.org|
|Peter MacCallum Cancer Centre||Recruiting|
|East Melbourne, Victoria, Australia, 3002|
|Contact: Shankar Siva +61 3 96561111|
|Principal Investigator: Shankar Siva|
|Principal Investigator:||Shankar Siva||Peter MacCallum Cancer Centre, Australia|