Spinal MetastasesPhase 3NCT02320825
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
A Phase 3 study testing single-fraction SRS, high-dose hypofractionated SRS and Quality of Life Measures in people with Spinal Metastases, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation. 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?
- single-fraction SRS, high-dose hypofractionated SRS and Quality of Life Measures
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Dec 2014to 26 Jul 2018
- Phase
- Phase 3
- 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
- Histologically diagnosed metastatic cancer (Diagnosis made or confirmed at MSKCC for MSKCC participants. Institutional pathologic determination accepted from participating multicenter sites.)
- Age ≥18 years
- Life expectancy ≥3 months
- ECOG ≤ 3
- Spinal surgery carried out with the goal of spinal cord decompression and spinal stabilization within 8 weeks
- Post-operative CT myelogram or MRI perfusion with evidence of separation of tumor and the spinal cord It should be noted that patients with multiple lesions will be eligible as long as there are no overlapping fields of radiation, including at various time frames.
Who cannot join
- Primary spine tumor
- Age < 18
- Pregnancy
- Lack of adequate (≥ 2 mm) separation between the spinal cord and the tumor on post-operative CT myelogram or MRI perfusion
- Radiosensitizing chemotherapy (taxol, taxotere, cisplatin, gemcitabine, 5-fluorouracil) given within one week of radiation treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
John Hopkins Medical Center
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford University Medical Center
Stanford, California, 94305-5408
About this study
Official title: Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.
- Conditions
- Spinal Metastases
- Being tested
- single-fraction SRS, high-dose hypofractionated SRS, Quality of Life Measures
- Keywords
- Stereotactic Radiosurgery (SRS), Single-Fraction, Hypofractionated, Spinal surgery, 14-233
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-fraction SRSRadiation
high-dose hypofractionated SRSRadiation
Quality of Life MeasuresBehavioural
| Study group | Role | What they receive |
|---|---|---|
| single-fraction SRS (24 Gy) | Experimental | single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. Receives: Radiation: single-fraction SRS; Behavioral: Quality of Life Measures |
| high-dose hypofractionated SRS (27 Gy in 3 fractions) | Experimental | hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery. Receives: Radiation: high-dose hypofractionated SRS; Behavioral: Quality of Life Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control Using MRI or CT
will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging.
Measured: 2 years
Secondary outcomes (2)
Treatment-related Toxicity Using CTCAE v4.0
Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 2 years
Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI
will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study start16 Dec 2014
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
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.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilya Laufer, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320825
- Sponsor's protocol ID
- 14-233
- Status last verified
- Jan 2019
- First submitted
- 16 Dec 2014
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
- ClinicalTrials.gov ID
- NCT02320825
- Acronym / sponsor ID
- 14-233
- Conditions
- Spinal Metastases
- Keywords
- Stereotactic Radiosurgery (SRS), Single-Fraction, Hypofractionated, Spinal surgery, 14-233
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Massachusetts General Hospital, Stanford University
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Posted 19 Feb 2019
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 whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-fraction SRS (24 Gy) | Experimental | Radiation: single-fraction SRS, Behavioral: Quality of Life Measuressingle-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. |
| high-dose hypofractionated SRS (27 Gy in 3 fractions) | Experimental | Radiation: high-dose hypofractionated SRS, Behavioral: Quality of Life Measureshypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically diagnosed metastatic cancer (Diagnosis made or confirmed at MSKCC for MSKCC participants. Institutional pathologic determination accepted from participating multicenter sites.)
- Age ≥18 years
- Life expectancy ≥3 months
- ECOG ≤ 3
- Spinal surgery carried out with the goal of spinal cord decompression and spinal stabilization within 8 weeks
Key exclusion criteria (5 listed)
- Primary spine tumor
- Age < 18
- Pregnancy
- Lack of adequate (≥ 2 mm) separation between the spinal cord and the tumor on post-operative CT myelogram or MRI perfusion
- Radiosensitizing chemotherapy (taxol, taxotere, cisplatin, gemcitabine, 5-fluorouracil) given within one week of radiation treatment
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 |
|---|---|---|
| single-fraction SRS | Radiation | single-fraction SRS (24 Gy) |
| high-dose hypofractionated SRS | Radiation | high-dose hypofractionated SRS (27 Gy in 3 fractions) |
| Quality of Life Measures | Behavioural | high-dose hypofractionated SRS (27 Gy in 3 fractions), single-fraction SRS (24 Gy) |
Primary outcome
Local Tumor Control Using MRI or CT
Time frame: 2 years
will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging.
2 secondary outcomes
Treatment-related Toxicity Using CTCAE v4.0
Time frame: 2 years
Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Spinal Metastases
RecruitingObservational study
Spine Oncology Registry
Spine Tumor, Spine Metastases
RecruitingPhase 2
Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
Chest Wall Tumor, Breast Cancer
Recruiting
The Effect of Radiotherapy After Separation Surgery for Spinal Metastases
Spinal Metastases, Spinal Tumor
Recruiting
Efficacy and Safety of Stereotactic Body Radiation Therapy for Spinal Metastases With Bilsky Grade 1c-3
Stereotactic Body Radiation Therapy (SBRT), Spinal Metastases
RecruitingObservational study
Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases
Spinal Metastases, Metastatic Epidural Spinal Cord Compression
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.
Ilya Laufer principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing single-fraction SRS, high-dose hypofractionated SRS and Quality of Life Measures in people with Spinal Metastases, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
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 6 inclusion and 5 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2019). 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?
Local Tumor Control Using MRI or CT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2019; AzTrials last refreshed its copy on 27 Oct 2026.