Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000759897
Ethics application status
Approved
Date submitted
17/07/2012
Date registered
17/07/2012
Date last updated
18/07/2018
Type of registration
Retrospectively registered

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 the feasibility of performing Focal Ablative Stereotactic Radiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases.
Secondary ID [1] 280816 0
Nil
Universal Trial Number (UTN)
U1111-1132-5574
Trial acronym
FASTRACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Renal Cell Carcinoma 286874 0
Metastatic non-small cell carcinoma to the adrenal gland 286889 0
Condition category
Condition code
Cancer 287199 287199 0 0
Kidney
Cancer 287210 287210 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For lesions less than 5cm - Image guided single fraction radiosurgery to26Gy prescribed to covering isodose. This is a single session of radiotherapy taking approximately 1 hour.
For lesions greater than or equal to 5cm - Image guided fractionated Stereotactic Body Radiotherapy (SBRT) to 45Gy in 3 fractions prescribed to covering isodose. This is 3 sessions of radiotherapy, delivered at least 48 hours apart, taking approximately 1 hour per session.
Prior to radiotherapy commencing, both treatment groups require a planning visit which will last approximately 1 hour, as well as a further 'mock-up' visit which will last approximately 45 minutes.
Intervention code [1] 285291 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287489 0
The number of patients who complete prescribed treatment. This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s).
Timepoint [1] 287489 0
Following treatment
Secondary outcome [1] 298278 0
Toxicity of SBRT in study patients measured using CTCAE V4.0
Specific toxicities will include, but are not limited to:
-Gastrointestinal (nausea, vomiting, diarrhoea, acute ulceration)
-Pulmonary (atelectasis, cough, dyspnoea, hypoxia, pleural effusion, fibrosis).
-Skin/chest wall (radiation dermatitis, rib fracture)
-Kidney (acute renal dysfunction)
Freedom from severe toxicity will be reported and defined as: time from treatment delivery until first recorded grade 4, or 5 toxicity as measured by CTCAE v 4.0
Timepoint [1] 298278 0
Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
Secondary outcome [2] 298279 0
Efficacy of stereotactic radiosurgery
Effective SBRT is defined as a treatment which results in local control at 1 year after treatment. Local control is defined as lack of progression of the target lesion as measured by RECIST criteria. RECIST criteria are an CT evaluation of change in tumour size.
Timepoint [2] 298279 0
1 year after treatment
Secondary outcome [3] 298280 0
Feasibility of using Diffusion weighted-MRI for Response Assessment: Feasibility will be measured by the quality of image of the Diffusion weighted-MRI scan recorded by the investigating radiologists.
Timepoint [3] 298280 0
At Baseline, 14 days (+/-3 days) and at the definitive respose assessment (70 days (+/- 10 days)

Eligibility
Key inclusion criteria
-Age > 18 years old
-All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:
(a) 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
(b) Cohort 2: solitary adrenal metastases with with primary 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. Targeted agents (such as sunitinib) are allowable.
-Any patient who is currently pregnant or breastfeeding.
-Previous high-dose radiotherapy to upper abdomen

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)
To register a patient onto the trial, an adequately qualified and authorized member of the research team at the trial site must complete the registration and eligibility Case Report Forms (CRFs) and forward them to the trials coordinator at the Peter MacCallum Centre Department of Radiation Oncology.
Prior to patient enrolment, the investigator should ensure that all of the following requirements are met:
*The patient meets all inclusion criteria and none of the exclusion criteria should apply.
*The patient has signed and dated the consent form
*All pre-treatment investigations and assessments have been performed.
*The eligibility checklist has been completed, signed and dated.
The Trial Coordinator will verify the completeness of the eligibility checklist upon receipt of the document and follow up with the participating investigator in the event of a discrepancy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
FASTRACK is a 2 -cohort, non-randomised prospective feasibility study.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2012
Actual
21/05/2012
Date of last participant enrolment
Anticipated
Actual
25/08/2014
Date of last data collection
Anticipated
Actual
12/10/2015
Sample size
Target
30
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285620 0
Charities/Societies/Foundations
Name [1] 285620 0
CASS Foundation
Country [1] 285620 0
Australia
Primary sponsor type
Individual
Name
Dr Shankar Siva
Address
Peter MacCallum Cancer Centre
Locked Bag 1 A'Beckett St
Vic 8006
Country
Australia
Secondary sponsor category [1] 284442 0
None
Name [1] 284442 0
Address [1] 284442 0
Country [1] 284442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287608 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 287608 0
Peter MacCallum Cancer Centre, 1 A'Beckett St, Melbourne, Victoria, 8006
Ethics committee country [1] 287608 0
Australia
Date submitted for ethics approval [1] 287608 0
Approval date [1] 287608 0
11/04/2012
Ethics approval number [1] 287608 0
11_106

Summary
Brief summary
Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be effective in controlling cancer in other sites in the body, including the lung and the liver. We aim to test the ability of this new technique to control cancers in the kidney. This is the first step of the research, and is a ‘pilot’ study.
Who is it for? You may be eligible to join this study if you are aged greater than 18 years and have a radiological diagnosis or biopsy confirmed diagnosis of either renal cell carcinoma or solitary adrenal metastases. Trial Details If you participate in this study, you will have either a single session of stereotactic body radiotherapy (SBRT) or three sessions of SBRT, depending on how big your cancer is. In order to deliver this treatment, you will need to attend a ‘planning’ session where your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be physically delivered when it comes to the time of treatment. This session will take approximately 45 minutes. When the treatment starts, the total time required to deliver the treatment will be one hour. In addition to the visits required to plan and deliver the radiotherapy, blood samples will be taken as part of this research. These will be taken at the same time as blood is collected to assess your kidney function (which would be standard care). Therefore will not require any additional blood collection visits than would be routinely performed to treat your cancer. Both the kidney function blood sample (standard of care) and the research related blood sample will be taken a total of 3 times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. If you have a primary kidney cancer (renal cell carcinoma), then in addition to the steps outlined above you will have a research related ‘Diffusion weighted-MRI’ scan performed a total of three times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. The Diffusion weighted-MRI scan is similar to a standard MRI scan, but is taken over a longer period of time. Each Diffusion weighted-MRI scan takes approximately 30 minutes. For those patients with adequate kidney function, you will also have a contrast injection at the time of the MRI, which will add an additional 10 minutes to the scan time. The MRI allows us to examine the blood flow into kidneys and the cancer.
To assess the function of the kidney after the SBRT treatment, a ‘positron emission tomography’ (PET) scan will be taken at approximately the same timepoints as the perfusion scans; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. This will involve injection of a radioactive tracer and a subsequent scan which will take approximately 30 minutes to capture. This will require you attending the PET Centre for a period of 2 or 3 hours. Participation in this study will involve no extra cost due to either having these scans or the treatment.
Trial website
Trial related presentations / publications
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.
https://www.ncbi.nlm.nih.gov/pubmed/?term=Stereotactic+Ablative+Body+Radiation+Therapy+for+Primary+Kidney+Cancer%3A+A+3-Dimensional+Conformal+Technique+Associated+With+Low+Rates+of+Early+Toxicity


https://insights.ovid.com/asia-pacific-clinical-oncology/apjco/2015/07/002/tolerability-stereotactic-ablative-body/29/01253234


Stereotactic ablative body radiotherapy for inoperable primary kidney cancer: a prospective clinical trial
https://onlinelibrary.wiley.com/doi/abs/10.1111/bju.13811




http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e16587
________________________________________
Assessing DCE-MRI and DWI as treatment response biomarkers after SABR for primary renal cell carcinoma.
Hayley M Reynolds, Bimal Parameswaran, Diana Roettger, Mary Finnegan, Eddie Lau, Tomas Kron, Mark Shaw, Sarat Chander, and Shankar Siva
Journal of Clinical Oncology 2018 36:15_suppl, e16587-e16587


Public notes

Contacts
Principal investigator
Name 34419 0
Dr Dr Shankar Siva
Address 34419 0
Department of Radiation Oncology Peter MacCallum Cancer Centre, Locked Bag 1 A'Beckett St, Vic 8006
Country 34419 0
Australia
Phone 34419 0
+61 3 85595000
Fax 34419 0
+61 3 8559 7729
Email 34419 0
[email protected]
Contact person for public queries
Name 17666 0
Dr Dr Shankar Siva
Address 17666 0
Department of Radiation Oncology Peter MacCallum Cancer Centre, Locked Bag 1 A'Beckett St, Vic 8006
Country 17666 0
Australia
Phone 17666 0
+61 3 85595000
Fax 17666 0
+61 3 8559 7729
Email 17666 0
[email protected]
Contact person for scientific queries
Name 8594 0
Dr Dr Shankar Siva
Address 8594 0
Department of Radiation Oncology Peter MacCallum Cancer Centre, Locked Bag 1 A'Beckett St, Vic 8006
Country 8594 0
Australia
Phone 8594 0
+61 3 85595000
Fax 8594 0
+61 3 8559 7729
Email 8594 0
[email protected]

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