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Trial registered on ANZCTR


Registration number
ACTRN12615000330549
Ethics application status
Approved
Date submitted
16/03/2015
Date registered
10/04/2015
Date last updated
12/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stereotactic Hypofractionated body radiosurgery for Oligometastatic Renal cell Tumours upfront, with Systemic Targeted agents On Progression
Scientific title
Effectiveness of Stereotactic Hypofractionated body radiosurgery for Oligometastatic Renal cell Tumours upfront, with Systemic Targeted agents On Progression
Secondary ID [1] 286225 0
Nil Known
Universal Trial Number (UTN)
U1111-1167-4273
Trial acronym
SHORTSTOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oligometastatic Renal Cell Cancer 294271 0
Condition category
Condition code
Cancer 294593 294593 0 0
Kidney
Renal and Urogenital 294851 294851 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stereotactic hypofractionated body radiosurgery (SABR).
Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy and uses a dose of radiation delivered in 1-3 treatments that is much higher than standard radiotherapy dosages. The recommended dose fractionation for this study is site-specific, and ranges from 18Gy/1Fx to 45Gy/3Fx. The total dose of radiation may be 5-10 times higher than standard radiotherapy doses. Generally, SABR treatment is given in a single 60 minute session, however, if more than one session of SABR treatment is required, this will be done on non-consecutive days within 14 days.
Intervention code [1] 291244 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294364 0
Local progression free survival (LPFS) at 1 year of patients receiving SABR.
Timepoint [1] 294364 0
2 year after completion of accrual. LPFS will be assessed by a combination of RECIST Criteria definitions taken using CT scans in participant's medical records. CT scans will be performed at baseline and then every 3 months during follow-up for each participant for up to 1 years.
Secondary outcome [1] 313103 0
Time to commencement of systemic agents or switching of systemic agents due to progression after SABR delivery.
Timepoint [1] 313103 0
2 years after completion of accrual, using information in participant's medical records.
Secondary outcome [2] 313104 0
Acute (within 3 months of start of SABR) and late (after 3 months but within 1 year of start of SABR) toxicities due to treatment using CTCAE V4.0.
Timepoint [2] 313104 0
5 years after completion of accrual. This outcome will be assessed within 3 months of start of SABR for acute toxicities and after 3 months but within 1 year of start of SABR for late toxicities.
Secondary outcome [3] 313105 0
Quality of life before and after SABR as assessed using the EORTC QLQ-C30.
Timepoint [3] 313105 0
2 years after completion of accural. Quality of life assessments will be performed at baseline, 1 month after SABR, and then three monthly during follow-up until 2 years after commencement of SABR for each participant.
Secondary outcome [4] 313106 0
Time to distant failure measured from the date of SABR treatment, defined as disease progression in any site not previously documented and measured from the date of SABR treatment to the date of first distant failure. Patients that died without documented distant failure will be censured.
Timepoint [4] 313106 0
2 years after completion of accrual.
Secondary outcome [5] 313107 0
Overall survival, defined as death from any cause measured from the date of SABR treatment to the date of death.
Timepoint [5] 313107 0
2 years after completion of accrual.

Eligibility
Key inclusion criteria
- Aged 18 years or older
- Histological or cytologically confirmed renal cell carcinoma
- Bone Scan or CT Scan evidence of 1 to 3 extracranial metastases in patients with no prior systemic targeted therapy
-Bone Scan or CT Scan evidence of 4 to 6 extracranial metastases in patients currently on systemic targeted therapy AND no more than 1 to 3 progressing metastases
- An ECOG performance status score of 2 or less
- Life expectancy greater than 9 months
- Available for follow up
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous high dose radiotherapy (BED > 20Gy) to the area to be treated
- Intracranial metastases not controlled by previous surgery or stereotactic radiotherapy
- Chemotherapy within +/- 3 weeks of SABR
- Systemic targeted agents within +/- 7 days of SABR
- Evidence of Spinal Cord Compression
- Spinal Instability Neoplastic Score >= 7 unless case has been reviewed by a neurosurgical service and considered stable
- Long bone Mirels score >= 7 unless reviewed by an orthopaedic service and considered stable

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)
The Investigator should ensure that all of the following requirements are met prior to patient enrolment:
1. The patient meets all inclusion criteria and none of the exclusion criteria apply.
2. The patient has signed and dated all applicable consent forms.
3. All baseline assessments and investigations have been performed and recorded in the patients’ medical records (i.e. source documents).
4. The registration and eligibility Case Report Form(s) (CRF) has been completed, signed and dated by the Investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a single arm pilot study.
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
12/08/2014
Actual
12/08/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
1/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3525 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 9288 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 290833 0
Self funded/Unfunded
Name [1] 290833 0
Foroudi Research Funds
Country [1] 290833 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 289524 0
None
Name [1] 289524 0
Address [1] 289524 0
Country [1] 289524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292455 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 292455 0
Level 4, 10 St Andrews Place
East Melbourne VIC 3002
Ethics committee country [1] 292455 0
Australia
Date submitted for ethics approval [1] 292455 0
Approval date [1] 292455 0
26/06/2014
Ethics approval number [1] 292455 0
14/05

Summary
Brief summary
This study aims to investigate the side effects, safety, and effectiveness of stereotactic hypofractionated body radiosurgery for oligometastatic renal cell tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically confirmed renal cell carcinoma and 1 to 3 extracranial metastases (with no prior systemic targeted therapy) or 4 to 6 extracranial metastases in patients currently on systemic targeted therapy AND no more than 1 to 3 progressing metastases. Study details Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. SABR treatment appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, spine, liver and kidney. We aim to test the ability of this new technique to control cancers that have spread beyond the kidney to other organs or to the bones. This study will involve discussing your medical history and progress of your renal cell tumour with the doctor. A whole body bone scan and CT scan of the chest, abdomen and pelvis will be performed to confirm the location and number of secondary deposits of the tumour prior to treatment and at follow up visits. In addition to the bone and CT scans, an additional scan called a diffusion and perfusion MRI will be used before treatment and 3 months after treatment to investigate the changes in cancer blood flow before and after treatment. Up to three sessions of SABR treatment will be performed, depending on the location of your secondary cancer deposits. As part of the study, blood samples will be taken before and after treatment at 5 timepoints over a period of approximately 3-4 months. Questionnaires looking at quality of life and pain will be completed before treatment, and at each follow up visit. Follow up visits will be performed at approximately 1 month, and every 3 months until 2 years after the radiotherapy treatment. This is the first step of the research, and is a ‘pilot’ study. If the technique is shown to be both feasible and tolerable for this pilot study of 30 patients, we would then look at expanding this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55166 0
Dr Shankar Siva
Address 55166 0
Division of Radiation Oncology and Cancer Imaging
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 55166 0
Australia
Phone 55166 0
+61 3 9656 1111
Fax 55166 0
+61 3 9656 1424
Email 55166 0
[email protected]
Contact person for public queries
Name 55167 0
Shankar Siva
Address 55167 0
Division of Radiation Oncology and Cancer Imaging
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 55167 0
Australia
Phone 55167 0
+61 3 9656 1111
Fax 55167 0
+61 3 9656 1424
Email 55167 0
[email protected]
Contact person for scientific queries
Name 55168 0
Shankar Siva
Address 55168 0
Division of Radiation Oncology and Cancer Imaging
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 55168 0
Australia
Phone 55168 0
+61 3 9656 1111
Fax 55168 0
+61 3 9656 1424
Email 55168 0
[email protected]

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

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