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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02613819




Registration number
NCT02613819
Ethics application status
Date submitted
4/11/2015
Date registered
25/11/2015
Date last updated
21/05/2020

Titles & IDs
Public title
Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney
Scientific title
Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)
Secondary ID [1] 0 0
TROG 15.03
Universal Trial Number (UTN)
Trial acronym
FASTRACK II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SABR

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


Treatment: Other: SABR
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.

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria - Responsive Evaluation Criteria in Solid Tumors (RECIST)
Timepoint [1] 0 0
12mths post treatment
Secondary outcome [1] 0 0
Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4 - Common Terminology Criteria for Adverse Events (CTCAE)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Estimated Survival after SABR assessed by clinincal assessment - Stereotactic Ablative Radiotherapy (SABR)
Timepoint [2] 0 0
assessed up to 60 months
Secondary outcome [3] 0 0
Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Renal Function Change after SABR assessed by split renal function and GFR - Calculated Glomular Filtration Rate (GFR)
Timepoint [4] 0 0
Baseline, 12mths post treatment, and 24 mths post treatment
Secondary outcome [5] 0 0
Renal Function Change after SABR assessed by using eGFR - Estimated Glomular Filtration Rate (eGFR)
Timepoint [5] 0 0
Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3000 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Trans-Tasman Radiation Oncology Group (TROG)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy
(SABR) for the treatment of kidney cancers.
Trial website
https://clinicaltrials.gov/show/NCT02613819
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shankar Siva, A/Prof
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications