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Trial registered on ANZCTR


Registration number
ACTRN12615001031550
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
1/10/2015
Date last updated
20/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Radiation treatment prior to surgery for local spine metastasis
Scientific title
A Phase II Study for the Treatment of Localised Spine Metastasis: Assessing the Safety and Efficacy of Image Guided Radiosurgery prior to Surgical Stabilisation.
Secondary ID [1] 287336 0
Nil
Universal Trial Number (UTN)
Trial acronym
LASERS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic solid (non-haematological) cancerous malignancies of the spine. 295976 0
Condition category
Condition code
Cancer 296257 296257 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo stereotactic body radiotherapy (SBRT) within 36 hours of being consented for the study. Participants will proceed to spinal surgery at least 7 days following the last SBRT treatment fraction.

Participants will receive either:
1) 16 Gy in a single fraction (radiosensitive histology);
2) 18 Gy in a single fraction (radioresistant histology); or
3) 24 Gy in two fractions, at one fraction per day, over two consecutive days in the same week (Mon to Fri) when spinal cord constraints cannot be met for 16 or 18 Gy plans.

The dose prescription and fractionation will be decided by the referring radiation oncologist based on cancer histology, tumour location and other factors. All treatments will be planned off a single simulation CT scan, and treatment will be delivered using daily kV orthogonal imaging with 6D correction and cone-beam computed tomography. Participant adherence will be monitored through the departmental record and verify system.
Intervention code [1] 292656 0
Treatment: Other
Comparator / control treatment
N/A (Phase II)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295915 0
Feasibility: The intervention will be deemed a feasible approach if at least 75% of participants fulfil 3 of the 4 following criteria:

1. Able to undergo preoperative Stereotactic Body Radiotherapy (SBRT) within 36 hours of obtaining consent.
2. Able to undergo surgery a minimum of 7 days after SBRT.
3. Able to lie flat for the duration of treatment (immobilisation)
4. Able to achieve a SBRT plan that meets the pre defined requirement in terms of target coverage and spinal cord tolerance.
Timepoint [1] 295915 0
SBRT will be delivered to the affected spinal segment within 36 hours of obtaining patient consent. Patients will proceed to surgery a minimum of 7 days after the last day of SBRT treatment.
Primary outcome [2] 295917 0
Tolerability: The intervention will be deemed tolerable if <15% of the participants experience Grade 4 or higher toxicities (CTCAE V4.0)
Timepoint [2] 295917 0
Toxicities will be assessed immediately after each treatment fraction, and at one month post SBRT and then every 3 months up to 24 months.
Secondary outcome [1] 316917 0
Change in pain from baseline (Numerical Rating Pain Scale)
Timepoint [1] 316917 0
1, 3, 6, 12, 15, 18, 21 and 24 months following SBRT
Secondary outcome [2] 316918 0
Change in neurological status from baseline (RTOG 0631)
Timepoint [2] 316918 0
1, 3, 6, 12, 15, 18, 21 and 24 months following SBRT

Eligibility
Key inclusion criteria
Males or females aged 18 to 85 (inclusive).
Histological diagnosis of a non-haematological malignancy.
Radiological (MRI or CT within 4 weeks) diagnosis of spinal metastases (C1-L5) who require surgery.
TOKUHASHI score of 9 or above.
Karnovsky performance score (KPS) > 70%.
Maximum involvement of two contiguous spinal levels.
Muscle power greater than 3/5.
Baseline NRPS greater or equal to 4 assessed within 36 hours prior to registration.
Ability to lie supine.
Women with child-bearing potential must have a negative serum pregnancy test and practice adequate contraception.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with rapidly progressive neurological symptoms.
Previous irradiation to the same spinal level.
Non-ambulatory status.
> 2 contiguous vertebral bodies involved.
> 2 treatment sites.
Predefined spinal cord tolerances cannot be met.
Chemotherapy or other systemic treatment <3 weeks prior to SBRT.
Taxane or Anthracycline containing chemotherapy < 4 weeks prior to, or concurrent with, SBRT.
Contraindications to radiological imaging and surgical intervention.

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
The exact 90 and 95% confidence intervals for a nominal or estimated feasibility proportion of 75% (15 of 20 patients) do not include a value of 50%, indicating that for a sample size of 20, a feasibility of 75% is above chance level performance (50%).

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)
VIC
Recruitment hospital [1] 4269 0
Epworth Richmond - Richmond
Recruitment hospital [2] 4270 0
Epworth Freemasons - Melbourne
Recruitment postcode(s) [1] 10214 0
3121 - Richmond
Recruitment postcode(s) [2] 10215 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 291919 0
Other
Name [1] 291919 0
Epworth Research Institute
Address [1] 291919 0
5 Hoddle St, Melbourne, VIC 3121
Country [1] 291919 0
Australia
Funding source category [2] 291920 0
Other
Name [2] 291920 0
The Perpetual Group, IMPACT Philanthropy. The Perpetual Group connects not-for-profits with philanthropists to provide funding for causes that align with donors' wishes.
Address [2] 291920 0
Level 35, Rialto South Tower, 525 Collins St Melbourne VIC 3000
Country [2] 291920 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
89 Bridge Road, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 290588 0
Individual
Name [1] 290588 0
Dr Neda Haghighi
Address [1] 290588 0
Level 4, 32 Erin St Richmond VIC 3121
Country [1] 290588 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293425 0
Epworth HREC
Ethics committee address [1] 293425 0
Pelaco Building One, 21–31 Goodwood Street, Richmond VIC 3121
Ethics committee country [1] 293425 0
Australia
Date submitted for ethics approval [1] 293425 0
12/08/2015
Approval date [1] 293425 0
31/08/2015
Ethics approval number [1] 293425 0
651-14

Summary
Brief summary
The primary purpose of this study is to determine whether Stereotactic Body Radiotherapy (SBRT) given prior to surgery is technically feasible and clinically safe for the treatment of patients with localised spine metastases. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years, have any non-haematological cancer type, and have been diagnosed with spinal metastases in the past 4 weeks for which spinal surgery has been prescribed. Study details: SBRT is a type of radiation therapy in which a few, very high, doses of radiation are very accurately delivered to a small, well-defined target area. It is normally delivered after surgery in the treatment of spinal metastases however this approach has a number of drawbacks. In this study, all participants will receive radiation treatment at least 7 days before surgery, with doses ranging between 16 – 24 Gy over 1-2 days. Patients will be assessed for signs of toxicity and pain at 1 then 3 monthly intervals for 2 years following the SBRT treatment. It is hoped that the findings of this trial will aid understanding of whether it is technically possible, and safe, to deliver SBRT prior to surgery for spinal metastases, in place of the current standard care in which SBRT is delivered following surgery.
Trial website
http://www.epworth.org.au/Our-Services/Cancer-Services/radiationoncology/Pages/Clinical-Trials.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59770 0
Dr Neda Haghighi
Address 59770 0
Epworth Radiation Oncology
Level 4, 32 Erin St Richmond VIC 3121
Country 59770 0
Australia
Phone 59770 0
+61 3 9936 8277
Fax 59770 0
Email 59770 0
Neda.Haghighi@epworth.org.au
Contact person for public queries
Name 59771 0
Dr Neda Haghighi
Address 59771 0
Epworth Radiation Oncology
Level 4, 32 Erin St Richmond VIC 3121
Country 59771 0
Australia
Phone 59771 0
+61 3 9936 8277
Fax 59771 0
Email 59771 0
Jo.Benhamu@epworth.org.au
Contact person for scientific queries
Name 59772 0
Dr Neda Haghighi
Address 59772 0
Epworth Radiation Oncology
Level 4, 32 Erin St Richmond VIC 3121
Country 59772 0
Australia
Phone 59772 0
+61 3 9936 8277
Fax 59772 0
Email 59772 0
Neda.Haghighi@epworth.org.au

No information has been provided regarding IPD availability
Summary results
No Results