Spinal MetastasesNCT02512965
Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases
A study testing 20 Gy in 5 fractions and Conventional SBRT: 24 Gy in 2 fractions in people with Spinal Metastases, run by Canadian Cancer Trials Group at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- 20 Gy in 5 fractions and Conventional SBRT: 24 Gy in 2 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 4 Jan 2016to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Canada14 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
London Regional Cancer Program
London, Ontario, N6A 5W9
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
BCCA - Centre for the North
Prince George, British Columbia, V2M 7E9
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Canberra Hospital
Garran, ACT 2605
Auckland City Hospital
Grafton, Aucklund, 1023
Royal Brisbane and Womens Hospital
Herston, 4029
Liverpool Cancer Therapy Centre, Liverpool Hospital
Liverpool, New South Wales, 2170
Peter McCallum Cancer Institute
Melbourne, Victoria, 3002
Peter Mac - Sunshine Hospital
St Albans, Victoria, 3021
About this study
Official title: A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Spinal Metastases
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.
Read the detailed description
This research is being done because while there is some evidence suggesting that SBRT may improve treatment for patients with spine metastases, more research is needed to determine if it is better than CRT. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting another 124 participants to receive either CRT or SBRT, using the same study procedure as in the feasibility study. We will continue to obtain information about whether SBRT is better than CRT at controlling pain.
- Conditions
- Spinal Metastases
- Being tested
- 20 Gy in 5 fractions, Conventional SBRT: 24 Gy in 2 fractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 Gy in 5 fractionsRadiation
Conventional SBRT: 24 Gy in 2 fractionsRadiation
| Study group | Role | What they receive |
|---|---|---|
| Standard Conventional Radiotherapy | Active comparator | Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions Receives: Radiation: 20 Gy in 5 fractions |
| Stereotactic Body Radiotherapy | Experimental | Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions Receives: Radiation: Conventional SBRT: 24 Gy in 2 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase III: Complete Pain Response at 3 Months Post-radiation
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) .
Measured: 3 months
Secondary outcomes (3)
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria
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) .
Measured: 6 months post radiation
Radiation Site Progression-free Survival Rate at 6 Months Using MRI Imaging
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.
Measured: 6 months.
Overall Survival Rate at 6 Months
Proportion of participants who were alive at 6 months in study.
Measured: 6 months post radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start4 Jan 2016
- Primary completion21 Jul 2020
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Trans Tasman Radiation Oncology Group
- Responsible party
- Sponsor
- Investigators
- Arjun Sahgal, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512965
- Sponsor's protocol ID
- SC24
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2015
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahgal A, Myrehaug SD, Siva S, Masucci GL, Maralani PJ, Brundage M, Butler J, Chow E, Fehlings MG, Foote M, Gabos Z, Greenspoon J, Kerba M, Lee Y, Liu M, Liu SK, Thibault I, Wong RK, Hum M, Ding K, Parulekar WR; trial investigators. Stereotactic body radiotherapy versus conventional external beam radiotherapy in patients with painful spinal metastases: an open-label, multicentre, randomised, controlled, phase 2/3 trial. Lancet Oncol. 2021 Jul;22(7):1023-1033. doi: 10.1016/S1470-2045(21)00196-0. Epub 2021 Jun 11.
PubMed 34126044Tseng CL, Soliman H, Myrehaug S, Lee YK, Ruschin M, Atenafu EG, Campbell M, Maralani P, Yang V, Yee A, Sahgal A. Imaging-Based Outcomes for 24 Gy in 2 Daily Fractions for Patients with de Novo Spinal Metastases Treated With Spine Stereotactic Body Radiation Therapy (SBRT). Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):499-507. doi: 10.1016/j.ijrobp.2018.06.047. Epub 2018 Jul 10.
PubMed 30003994
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Spinal Metastases
- ClinicalTrials.gov ID
- NCT02512965
- Acronym / sponsor ID
- SC24
- Conditions
- Spinal Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Trans Tasman Radiation Oncology Group
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Posted 16 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research is being done because while there is some evidence suggesting that SBRT may improve treatment for patients with spine metastases, more research is needed to determine if it is better than CRT. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting another 124 participants to receive either CRT or SBRT, using the same study procedure as in the feasibility study. We will continue to obtain information about whether SBRT is better than CRT at controlling pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Conventional Radiotherapy | Active comparator | Radiation: 20 Gy in 5 fractionsStandard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions |
| Stereotactic Body Radiotherapy | Experimental | Radiation: Conventional SBRT: 24 Gy in 2 fractionsStereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 Gy in 5 fractions | Radiation | Standard Conventional Radiotherapy |
| Conventional SBRT: 24 Gy in 2 fractions | Radiation | Stereotactic Body Radiotherapy |
Primary outcome
Phase III: Complete Pain Response at 3 Months Post-radiation
Time frame: 3 months
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) .
3 secondary outcomes
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria
Time frame: 6 months post radiation
Radiation Site Progression-free Survival Rate at 6 Months Using MRI Imaging
Time frame: 6 months.
Overall Survival Rate at 6 Months
Time frame: 6 months post radiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34126044Sahgal A, Myrehaug SD, Siva S, Masucci GL, Maralani PJ, Brundage M, Butler J, Chow E, Fehlings MG, Foote M, Gabos Z, Greenspoon J, Kerba M, Lee Y, Liu M, Liu SK, Thibault I, Wong RK, Hum M, Ding K, Parulekar WR; trial investigators. Stereotactic body radiotherapy versus conventional external beam radiotherapy in patients with painful spinal metastases: an open-label, multicentre, randomised, controlled, phase 2/3 trial. Lancet Oncol. 2021 Jul;22(7):1023-1033. doi: 10.1016/S1470-2045(21)00196-0. Epub 2021 Jun 11.
- Derived from this study: PubMed 30003994Tseng CL, Soliman H, Myrehaug S, Lee YK, Ruschin M, Atenafu EG, Campbell M, Maralani P, Yang V, Yee A, Sahgal A. Imaging-Based Outcomes for 24 Gy in 2 Daily Fractions for Patients with de Novo Spinal Metastases Treated With Spine Stereotactic Body Radiation Therapy (SBRT). Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):499-507. doi: 10.1016/j.ijrobp.2018.06.047. Epub 2018 Jul 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arjun Sahgal study chair
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 Gy in 5 fractions and Conventional SBRT: 24 Gy in 2 fractions in people with Spinal Metastases, run by Canadian Cancer Trials Group at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase III: Complete Pain Response at 3 Months Post-radiation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512965, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.