Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney
- Conditions
- Renal Cell Carcinoma
- Interventions
- Radiation: SABR
- Registration Number
- NCT02613819
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- Brief Summary
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic Ablative Body Radiotherapy SABR Stereotactic Ablative Body Radiotherapy (SABR) Treatment schedule 1: 26 Gray (Gy) in 1 fraction, for tumours of less than or equal to 4cm in size. Treatment schedule 2: 42 Gray (Gy) in 3 fractions, for tumours of greater than 4cm in size
- Primary Outcome Measures
Name Time Method Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria 12mths post treatment Responsive Evaluation Criteria in Solid Tumors (RECIST)
- Secondary Outcome Measures
Name Time Method Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4 From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment Common Terminology Criteria for Adverse Events (CTCAE)
Estimated Survival after SABR assessed by clinincal assessment assessed up to 60 months Stereotactic Ablative Radiotherapy (SABR)
Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed from 6 mths, 9 mths, 12 mths, 18mths, 33 mths, 42 mths, 51 mths, and 60 mths post treatment Renal Function Change after SABR assessed by split renal function and GFR Baseline, 12mths post treatment, and 24 mths post treatment Calculated Glomular Filtration Rate (GFR)
Renal Function Change after SABR assessed by using eGFR Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths Estimated Glomular Filtration Rate (eGFR)
Trial Locations
- Locations (1)
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia