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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
Not applicable
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
Not applicable
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
This is a "proof of concept" study, to assess the feasibility of introducing a novel high-precision radiotherapy technique called "stereotactic radiosurgery" (SRS) or "stereotactic body radiotherapy" (SBRT) for the treatment of kidney cancers in Australia. This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated adrenal metastases from non-small cell carcinoma who are either medically inoperable, high risk for surgery, or decline surgery to participate. In cohort of patients with renal cell carcinoma, both patients with primary disease only, and those patients who have limited metastases (=5) will be eligible. Besides technical feasibility of delivering this treatment, this study will be to assess efficacy, toxicity and tumour response using a novel imaging biomarker called diffusion weighted-MRI.
Trial website
https://clinicaltrials.gov/study/NCT01676428
Trial related presentations / publications
Pham D, Thompson A, Kron T, Foroudi F, Kolsky MS, Devereux T, Lim A, Siva S. Stereotactic ablative body radiation therapy for primary kidney cancer: a 3-dimensional conformal technique associated with low rates of early toxicity. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1061-8. doi: 10.1016/j.ijrobp.2014.07.043. Epub 2014 Oct 13.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01676428