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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02512965
Registration number
NCT02512965
Ethics application status
Date submitted
27/07/2015
Date registered
31/07/2015
Date last updated
13/02/2024
Titles & IDs
Public title
Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases
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Scientific title
A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Spinal Metastases
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Secondary ID [1]
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SC24
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Metastases
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - 20 Gy in 5 fractions
Treatment: Other - Conventional SBRT: 24 Gy in 2 fractions
Active Comparator: Standard Conventional Radiotherapy - Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions
Experimental: Stereotactic Body Radiotherapy - Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions
Treatment: Other: 20 Gy in 5 fractions
Treatment: Other: Conventional SBRT: 24 Gy in 2 fractions
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase III: Complete Pain Response at 3 Months Post-radiation
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Assessment method [1]
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A Complete Pain Response is defined as a pain score of zero (0) at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalent) .
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria
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Assessment method [1]
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A Complete Pain Response is defined as a pain score of zero (0) at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalent) .
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Timepoint [1]
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6 months post radiation
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Secondary outcome [2]
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Radiation Site Progression-free Survival Rate at 6 Months Using MRI Imaging
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Assessment method [2]
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Radiation site progression was defined as:
Gross unequivocal increase in tumor volume or linear dimension > 20%.
Any new or progressive tumor within the epidural space.
Neurologic deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions on MRI.
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Timepoint [2]
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6 months.
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Secondary outcome [3]
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Overall Survival Rate at 6 Months
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Assessment method [3]
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Proportion of participants who were alive at 6 months in study.
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Timepoint [3]
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6 months post radiation
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Eligibility
Key inclusion criteria
- Histologic or cytologic diagnosis of cancer (excluding seminoma, small cell lung
cancer and hematologic primaries).
- Spinal metastasis documented with MRI and suitable for treatment with radiotherapy
with the following characteristics:
- Painful, as defined by a pain score = 2 for worst pain in the planned target
treatment volume;
- = 3 consecutive spinal segments involved by tumour to be included in the planned
target volume. The patient may have other spinal metaastases to be treated as per
the radiation oncologist's discretion, but the eligible spinal metastatic site
has to be one where there is pain and no more than 3 consecutive segments to be
included as clinical target volume and appropriate for either 20 Gy in 5
fractions or 24 Gy in 2 fractions per the randomization.
- There is no plan to change the pain medication on the first day of protocol treatment
with radiotherapy.
- ECOG Performance Status 0-2.
- Seen by a radiation oncologist and judged to be appropriate for participation in this
study including ability to tolerate protocol radiotherapy (SBRT or CRT).
- Age of 18 years or older.
- Patient is able and willing to complete the Patient Diary (pain and analgesic use).
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life
questionnaire in either English or French. The baseline assessment must be completed
within required timelines, prior to randomization. Inability (illiteracy in English or
French, loss of sight, or other equivalent reason) to complete the questionnaires will
not make the patient ineligible for the study. However, ability but unwillingness to
complete the questionnaires will make the patient ineligible.
- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements. Each patient must sign a consent form prior to enrollment in
the trial to document their willingness to participate.
- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.
- In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of
patient randomization. From the time of successful treatment planning, no more than 12
days can elapse before the first fraction of radiotherapy is delivered.
- Women/men of childbearing potential must have agreed to use a highly effective
contraceptive method. A woman is considered to be of "childbearing potential" if she
has had menses at any time in the preceding 12 consecutive months. In addition to
routine contraceptive methods, "effective contraception" also includes heterosexual
celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy
prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal
ligation, or vasectomy/vasectomized partner. However, if at any point a previously
celibate patient chooses to become heterosexually active during the time period for
use of contraceptive measures outlined in the protocol, he/she is responsible for
beginning contraceptive measures.
- Women of childbearing potential will have a pregnancy test to determine eligibility as
part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy
if a false-positive is suspected. For example, when beta-human chorionic gonadotropin
is high and partner is vasectomized, it may be associated with tumour production of
hCG, as seen with some cancers. Patient will be considered eligible if an ultrasound
is negative for pregnancy.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who have a pacemaker, such that MRI cannot be performed or treatment cannot
be delivered safely.
- Patients with prior treatment with any radionuclide within 30 days prior to
randomization.
- Patients with prior radiation to the spinal segment intended to be treated with
protocol radiotherapy such that the protocol therapy cannot be delivered as intended.
- Patients with prior surgery to the spinal segment intended to be treated with protocol
radiotherapy.
- Patients who have received chemotherapy within 1 week prior to administration of
protocol radiotherapy or who are expected/planned to receive chemotherapy within one
week of completing protocol radiotherapy. Centre guidelines regarding administration
of targeted non-cytotoxic therapy must be followed with the proviso that no systemic
anticancer therapy should be administered within 24 hours prior to and
post-radiotherapy. Endocrine therapy may be administered during radiotherapy as per
the discretion of the treating physician.
- Patients with spine instability as judged by a Spinal Instability Neoplastic Score
(SINS) of more than 12.
- Patients with symptomatic spinal cord compression or cauda equina syndrome resulting
from bony compression or epidural compression of the spinal cord and cauda equina,
respectively. Symptomatic refers to neurolic deficit in the form of motor, bowel or
bladder dysfunction.
- Pregnant or lactating women.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/01/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/08/2021
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Sample size
Target
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Accrual to date
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Final
229
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Recruitment in Australia
Recruitment state(s)
AucklundNSW,QLD,SA,VIC
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Recruitment hospital [1]
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Auckland City Hospital - Grafton
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Recruitment hospital [2]
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Liverpool Cancer Therapy Centre, Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [4]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [5]
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Peter McCallum Cancer Institute - Melbourne
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Recruitment hospital [6]
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Peter Mac - Sunshine Hospital - St Albans
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Recruitment hospital [7]
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Canberra Hospital - Garran
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Recruitment hospital [8]
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Royal Brisbane and Womens Hospital - Herston
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Recruitment postcode(s) [1]
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1023 - Grafton
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3002 - Melbourne
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Recruitment postcode(s) [6]
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3021 - St Albans
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Recruitment postcode(s) [7]
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ACT 2605 - Garran
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Recruitment postcode(s) [8]
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4029 - Herston
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Manitoba
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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Canada
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State/province [5]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Canadian Cancer Trials Group
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Trans Tasman Radiation Oncology Group
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to find out if SBRT is better than CRT at controlling pain in
the spine 3 months after receiving treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02512965
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Arjun Sahgal
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Address
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Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02512965
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