Trial registered on ANZCTR


Trial ID
ACTRN12615001181594
Ethics application status
Approved
Date submitted
19/10/2015
Date registered
3/11/2015
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)
Scientific title
A Mulicentre Phase II clinical Trial of STereotactic Ablative Body Radiotherapy for Primary Kidney Cancer
Secondary ID [1] 287666 0
TROG 15.03
Universal Trial Number (UTN)
U1111-1170-4329
Trial acronym
FASTRACK II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal cell carcinoma with a single lesion within a kidney

296495 0
Primary kidney tumour intact and no more than 5 documented metastases 296496 0
Condition category
Condition code
Cancer 296756 296756 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stereotactic Radiotherapy in two schedules depending on tumor size:
Fraction schedule 1: 26Gy in 1 fraction, for tumours of less than or equal to 4cm in size
Fraction schedule 2: 42Gy in 3 fractions, for tumours of greater than 4cm in size (i.e. 14Gy per fraction, given in 3 fractions over a max of 3 weeks, each fraction given on non consecutive days)

Intervention code [1] 293056 0
Treatment: Other
Intervention code [2] 293159 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296365 0
To estimate the activity and efficacy of the technique (composite outcome)
Timepoint [1] 296365 0
Freedom from local progression assessed by RECIST criteria at 12 mths.
Secondary outcome [1] 318270 0
Tolerability of SABR

Timepoint [1] 318270 0
Assessed as cummulative incidents of severy toxicity by CTCAE v4 from date of treatment commencement until end of study
Secondary outcome [2] 318271 0
Estimate survival after SABR

Timepoint [2] 318271 0
Assessed by clinical assessment at 24 mths post treatment
Secondary outcome [3] 318272 0
Estimate the distant failure rate after SABR
Timepoint [3] 318272 0
Distant failure assessed by CT scan and clinical assessment
24 mths post treatment
Secondary outcome [4] 318273 0
Describe renal function change after SABR
Timepoint [4] 318273 0
Assessed by serum creatine and eGFR using a Cockroft Gault method
1 year post treatment and 2 years post treatment

Eligibility
Key inclusion criteria
1. Age > 18 years old
2. All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
3. ECOG performance of 0-2 inclusive.
4. Life expectancy > 9 months
5. Either medically inoperable, technically high risk for surgery or decline surgery.
6. 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
1. 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.
2. Previous high-dose radiotherapy to an overlapping region
3. Tumours of larger than 8cm is size

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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)
Safety/efficacy
Statistical methods / analysis
Baseline characteristics will be summarised using descriptive statistics including counts and percentages for categorical variables and mean, standard deviation (SD), median and range for continuous variables.
The Kaplan-Meier method will be used to estimate the overall survival, freedom from local progression and freedom from distant progression. Annual estimates will be provided alongside with 95% confidence intervals.
Cumulative incidence curves for cancer related death and for severe toxicity will be provided assuming competing risks with death as a competing event. Annual estimates will be provided alongside with 95% confidence intervals estimated using bootstrap.
No imputation of missing values and no adjustments for multiplicity are intended. All confidence intervals provided will be 2-sided with alpha=0.05.

With a sample size of 70, alpha of 0.05, the 95% confidence interval width of freedom from local progression of 90% is 80-90%.

Recruitment
Recruitment status
Recruiting
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)
NSW,QLD,VIC
Recruitment hospital [1] 4467 0
Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors
Funding source category [1] 292219 0
Commercial sector/Industry
Name [1] 292219 0
Varian Medical Systems
Address [1] 292219 0
13A Narabang Way
Belrose NSW 2085
Country [1] 292219 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
TROG Cancer Research
PO Box 88
Waratah, NSW 2289
Country
Australia
Secondary sponsor category [1] 290897 0
None
Name [1] 290897 0
Address [1] 290897 0
Country [1] 290897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293692 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 293692 0
Ethics committee country [1] 293692 0
Australia
Date submitted for ethics approval [1] 293692 0
01/12/2015
Approval date [1] 293692 0
09/05/2016
Ethics approval number [1] 293692 0

Summary
Brief summary
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.

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

1. ECOGperformance of 0-2 inclusive.
2. Life expectancy > 9 months
3. Either medically inoperable, technically high risk for surgery or decline surgery.
4. 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.
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).

Trial website
www.trog.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60978 0
Dr Shankar Siva
Address 60978 0
Peter MacCallum Cancer Centre
Locked Bag 1
A' Beckett Street,
East Melbourne, Victoria, 8006
Country 60978 0
Australia
Phone 60978 0
+61 3 9656 1851
Fax 60978 0
Email 60978 0
shankar.siva@petermac.org.au
Contact person for public queries
Name 60979 0
Ms Courtney Hill
Address 60979 0
TROG Cancer Research
PO Box 88
Waratah, NSW 2289
Country 60979 0
Australia
Phone 60979 0
+61 02 401 43900
Fax 60979 0
Email 60979 0
trog@trog.com.au
Contact person for scientific queries
Name 60980 0
Dr Shankar Siva
Address 60980 0
Peter MacCallum Cancer Centre
Locked Bag 1
A' Beckett Street,
East Melbourne, Victoria, 8006
Country 60980 0
Australia
Phone 60980 0
+61 3 9656 1851
Fax 60980 0
Email 60980 0
shankar.siva@petermac.org.au