Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney (FASTRACK II)
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|ClinicalTrials.gov Identifier: NCT02613819|
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Radiation: SABR||Phase 2|
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
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Official Title:||Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Stereotactic Ablative Body Radiotherapy
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
Renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated External beam radiation therapy (EBRT) in the form of stereotactic radiotherapy will be used in the management of renal cell carcinoma with radiotherapy.
Other Name: Stereotactic Ablative Body Radiotherapy
- Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria [ Time Frame: 12mths post treatment ]Responsive Evaluation Criteria in Solid Tumors (RECIST)
- Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4 [ Time Frame: 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 [ Time Frame: assessed up to 60 months ]Stereotactic Ablative Radiotherapy (SABR)
- Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment [ Time Frame: 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 [ Time Frame: Baseline, 12mths post treatment, and 24 mths post treatment ]Calculated Glomular Filtration Rate (GFR)
- Renal Function Change after SABR assessed by using eGFR [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613819
|Contact: Courtney Hill||+61 02 401 email@example.com|
|Peter MacCallum Cancer Centre||Recruiting|
|East Melbourne, Victoria, Australia, 3000|
|Contact: Jenny Trinh +61 3 8559 8482 Jenny.Trinh@petermac.org|
|Principal Investigator: Shankar Siva|
|Principal Investigator:||Shankar Siva, A/Prof||Peter MacCallum Cancer Centre, Australia|