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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02512965




Registration number
NCT02512965
Ethics application status
Date submitted
27/07/2015
Date registered
31/07/2015
Date last updated
3/04/2020

Titles & IDs
Public title
Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases
Scientific title
A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Spinal Metastases
Secondary ID [1] 0 0
SC24
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Metastases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The ability to randomize 54 patients with spinal metastases in Phase 2 measured by number of patients randomized to the trial
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Phase III: Complete pain response at 3 months post-radiation measured by the Cochran-Mantel-Hanzeal test
Timepoint [2] 0 0
18 months
Secondary outcome [1] 0 0
Complete pain response based on the International Bone Metastases Consensus Working Party Criteria
Timepoint [1] 0 0
6 months post radiation
Secondary outcome [2] 0 0
Radiation site progression-free survival using MRI imaging
Timepoint [2] 0 0
3 and 6 months post radiation
Secondary outcome [3] 0 0
Number and severity of adverse events using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0)
Timepoint [3] 0 0
3 and 6 months post radiation
Secondary outcome [4] 0 0
Health-related Quality of Life measured by the Bone Metastases Module (QLQ-BM22) instrument
Timepoint [4] 0 0
3 and 6 months post radiation
Secondary outcome [5] 0 0
Health-related Quality of Life measured by the EORTC QLQ-C30 instrument
Timepoint [5] 0 0
3 and 6 months post radiation
Secondary outcome [6] 0 0
Economic analysis as measured by the EuroQoL Health Questionnaire (EQ-5D-5L) instrument
Timepoint [6] 0 0
3 and 6 months post radiation
Secondary outcome [7] 0 0
Radiotherapy Quality Assurance compliance consisting of investigator credentialing, Prospective centre based individual pre-treatment case review and Retrospective external individual post-treatment case review.
Timepoint [7] 0 0
Immediately pre and immediately post treatment
Secondary outcome [8] 0 0
Overall Survival
Timepoint [8] 0 0
3 and 6 months post radiation
Secondary outcome [9] 0 0
Spinal Instability Neoplastic Score
Timepoint [9] 0 0
3 and 6 months post radiation

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
AucklundNSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Auckland City Hospital - Grafton
Recruitment hospital [2] 0 0
Liverpool Cancer Therapy Centre, Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Peter McCallum Cancer Institute - Melbourne
Recruitment hospital [6] 0 0
Peter Mac - Sunshine Hospital - St Albans
Recruitment hospital [7] 0 0
Canberra Hospital - Garran
Recruitment hospital [8] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment postcode(s) [1] 0 0
1023 - Grafton
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3002 - Melbourne
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment postcode(s) [7] 0 0
ACT 2605 - Garran
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans-Tasman Radiation Oncology Group (TROG)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02512965
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arjun Sahgal
Address 0 0
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
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
Other publications