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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01676428




Registration number
NCT01676428
Ethics application status
Date submitted
14/08/2012
Date registered
31/08/2012
Date last updated
1/11/2016

Titles & IDs
Public title
A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases
Scientific title
A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases
Secondary ID [1] 0 0
U1111-1132-5574
Secondary ID [2] 0 0
11/106
Universal Trial Number (UTN)
Trial acronym
FASTRACK
Linked study record

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

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

Experimental: Radiotherapy - 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.


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

Outcomes
Primary outcome [1] 0 0
The number of patients who complete prescribed treatment.
Timepoint [1] 0 0
After 24 months
Secondary outcome [1] 0 0
Toxicity of SBRT in study patients measured using CTCAE V4.0
Timepoint [1] 0 0
Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
Secondary outcome [2] 0 0
Efficacy of stereotactic radiosurgery
Timepoint [2] 0 0
1 year after treatment
Secondary outcome [3] 0 0
Feasibility of using Diffusion weighted-MRI for response assessment.
Timepoint [3] 0 0
At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)

Eligibility
Key inclusion criteria
* Age > 18 years old
* All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:

1. Cohort 1: renal cell carcinoma with a single lesion within kidney, or with primary kidney tumour intact and no more than 5 documented metastases, or
2. Cohort 2: single adrenal metastases with extra-adrenal disease controlled
* ECOG performance of 0-2 inclusive.
* Either medically inoperable, technically high risk for surgery or decline surgery.
* Informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 upper abdomen

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shankar Siva
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01676428