NCT02512965 is a NA clinical trial of 20 Gy in 5 fractions in Spinal Metastases, sponsored by Canadian Cancer Trials Group.

Who is sponsoring NCT02512965?

NCT02512965 is sponsored by Canadian Cancer Trials Group.

What drugs are being tested in NCT02512965?

Interventions in NCT02512965: 20 Gy in 5 fractions, Conventional SBRT: 24 Gy in 2 fractions.

What condition does NCT02512965 study?

NCT02512965 studies Spinal Metastases.

Is NCT02512965 still recruiting?

NCT02512965 is currently completed. Last updated 13 February 2024.

Are results published for NCT02512965?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-13 · How we verify

NCT02512965

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases

Completed NA Results posted Last updated 13 February 2024

What this trial tests

NA trial testing 20 Gy in 5 fractions in Spinal Metastases in 229 participants. Completed in 16 August 2021.

Timeline

4 January 2016

Primary endpoint
21 July 2020

16 August 2021

Quick facts

Lead sponsor	Canadian Cancer Trials Group
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	229
Start date	4 January 2016
Primary completion	21 July 2020
Estimated completion	16 August 2021
Sites	22 locations across Canada, Australia

Drugs / interventions tested

20 Gy in 5 fractions
Conventional SBRT: 24 Gy in 2 fractions

Conditions studied

Spinal Metastases — all drugs for Spinal Metastases →

Sponsor

Canadian Cancer Trials Group — full company profile →

Who can join

18 and older, any sex, with Spinal Metastases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase III: Complete Pain Response at 3 Months Post-radiation Primary · 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) .

Group	Value	95% CI
Standard Conventional Radiotherapy	16
Stereotactic Body Radiotherapy	40

Group	Value	95% CI
Standard Conventional Radiotherapy	29
Stereotactic Body Radiotherapy	20

Group	Value	95% CI
Standard Conventional Radiotherapy	34
Stereotactic Body Radiotherapy	27

Group	Value	95% CI
Standard Conventional Radiotherapy	14
Stereotactic Body Radiotherapy	7

In-evalable

Group	Value	95% CI
Standard Conventional Radiotherapy	22
Stereotactic Body Radiotherapy	16

Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria Secondary · 6 months post radiation

Group	Value	95% CI
Standard Conventional Radiotherapy	18
Stereotactic Body Radiotherapy	37

Group	Value	95% CI
Standard Conventional Radiotherapy	18
Stereotactic Body Radiotherapy	10

Group	Value	95% CI
Standard Conventional Radiotherapy	32
Stereotactic Body Radiotherapy	26

Group	Value	95% CI
Standard Conventional Radiotherapy	8
Stereotactic Body Radiotherapy	5

In-evaluable

Group	Value	95% CI
Standard Conventional Radiotherapy	39
Stereotactic Body Radiotherapy	36

Radiation Site Progression-free Survival Rate at 6 Months Using MRI Imaging Secondary · 6 months.

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.

Group	Value	95% CI
Standard Conventional Radiotherapy	0.69	0.60 – 0.77
Stereotactic Body Radiotherapy	0.75	0.65 – 0.82

Overall Survival Rate at 6 Months Secondary · 6 months post radiation

Proportion of participants who were alive at 6 months in study.

Group	Value	95% CI
Standard Conventional Radiotherapy	0.73	0.64 – 0.81
Stereotactic Body Radiotherapy	0.77	0.68 – 0.84

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Conventional Radiotherapy

Serious: 4/115 (3%)

Deaths: 30/115

Stereotactic Body Radiotherapy

Serious: 3/110 (3%)

Deaths: 25/114

Serious adverse events (8 terms)

Reaction	System	Standard Conventional Radi…	Stereotactic Body Radiothe…
Dysphagia	Gastrointestinal disorders	—	—
Esophagitis	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Pain	General disorders	—	—
Spinal fracture	Injury, poisoning and procedural complications	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Standard Conventional Radi…	Stereotactic Body Radiothe…
Back pain	Musculoskeletal and connective tissue disorders	—	—
Pain	General disorders	—	—

Most-reported serious reactions: Dysphagia, Esophagitis, Nausea, Fatigue, Pain, Spinal fracture, Dehydration, Neck pain.

Data from ClinicalTrials.gov NCT02512965 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Stereotactic body radiotherapy versus conventional external beam radiotherapy in patients with painful spinal metastases: an open-label, multicentre, randomised, controlled, phase 2/3 trial.
Sahgal A, Myrehaug SD, Siva S, Masucci GL, et al · · 2021 · cited 269× · PMID 34126044 · DOI 10.1016/s1470-2045(21)00196-0
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).
Tseng CL, Soliman H, Myrehaug S, Lee YK, et al · · 2018 · cited 91× · PMID 30003994 · DOI 10.1016/j.ijrobp.2018.06.047
Current concepts in bone metastasis, contemporary therapeutic strategies and ongoing clinical trials.
Gdowski AS, Ranjan A, Vishwanatha JK. · · 2017 · cited 83× · PMID 28800754 · DOI 10.1186/s13046-017-0578-1
Separation surgery for metastatic epidural spinal cord compression: A qualitative review.
Di Perna G, Cofano F, Mantovani C, Badellino S, et al · · 2020 · cited 60× · PMID 33088700 · DOI 10.1016/j.jbo.2020.100320
Decision Making in Patients With Metastatic Spine. The Role of Minimally Invasive Treatment Modalities.
Conti A, Acker G, Kluge A, Loebel F, et al · · 2019 · cited 56× · PMID 31608228 · DOI 10.3389/fonc.2019.00915
Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation.
Huo M, Sahgal A, Pryor D, Redmond K, et al · · 2017 · cited 37× · PMID 28303210 · DOI 10.4103/2152-7806.200581
Recent advances and new discoveries in the pipeline of the treatment of primary spinal tumors and spinal metastases: a scoping review of registered clinical studies from 2000 to 2020.
Furlan JC, Wilson JR, Massicotte EM, Sahgal A, et al · · 2022 · cited 24× · PMID 34508647 · DOI 10.1093/neuonc/noab214
Management of recurrent or progressive spinal metastases: reirradiation techniques and surgical principles.
Kotecha R, Dea N, Detsky JS, Sahgal A. · · 2020 · cited 16× · PMID 33299573 · DOI 10.1093/nop/npaa045

Verify or expand the search:

Other recruiting trials for Spinal Metastases

Currently open trials in the same condition.

NCT06548061 — D20054;LITT for Spine Tumors · NA · recruiting
NCT06244264 — The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis · NA · recruiting
NCT06120426 — En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor · recruiting
NCT05575323 — Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases · NA · recruiting
NCT07429422 — SBRT Technique Implementation for Spinal Metastases Irradiation · NA · recruiting

Other Canadian Cancer Trials Group trials

Trials by the same sponsor.

NCT07390435 — Feasibility and Acceptability of Collecting Sociodemographic Data in CCTG Trials · not yet recruiting
NCT07297667 — GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours · Phase 1 · not yet recruiting
NCT06630273 — Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherape · not yet recruiting
NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02512965 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Canadian Cancer Trials Group
Last refreshed: 13 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02512965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing