Solid Tumor Spine MetastasesPhase 2NCT01752036
Radiotherapy for Solid Tumor Spine Metastases
A Phase 2 study testing Post-operative, Stereotactic Body Radiation Therapy (SBRT) in people with Solid Tumor Spine Metastases, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Solid Tumor Spine Metastases
- What is being tested?
- Post-operative, Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2013to 27 Jul 2018
- Phase
- Phase 2
- 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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥12 years
- Histologically proven solid tumor malignancy with metastasis to the spine. Diagnosis may be acquired from needle biopsy, cytology, or surgical biopsy or resection.
- Radiographic evidence of spinal metastasis is required and may be obtained from plain radiographs, radionuclide bone scans, computed tomography imaging, and magnetic resonance imaging. Other studies may be used with principal investigator approval.
- The patient must have undergone surgical resection resection (gross total, subtotal, or biopsy) of the spinal lesion(s) no more than 12 weeks prior to SRS treatment.
- Treating physician must deem that SRS is appropriate treatment for the metastatic spinal lesion(s).
- Each SRS target must be the equivalent of ≤3 vertebral levels
Show all 9Show fewer
- The patient must have a Karnofsky Performance Score of 40 or greater
- If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 12 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior radiation or radiosurgery to the involved level of the spine
- Spine disease from leukemia, lymphoma or myeloma
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 1 year.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
- Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases
Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. The primary objective of this study is to evaluate radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared to the expected rate following conventional radiation therapy.
Read the detailed description
This is a phase II trial evaluating the rate radiographic local recurrence following post-operative stereotactic radiosurgery boost in patients with metastatic solid malignancies with spine metastases status post resection. Patients will be treated with 600 cGy x 5 fractions to the tumor bed and then followed both clinically and radiographically to determine if local recurrence following this treatment is better than might be expected for conventional radiation therapy.
- Conditions
- Solid Tumor Spine Metastases
- Being tested
- Post-operative, Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- stereotactic radiotherapy, SRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative, Stereotactic Body Radiation Therapy (SBRT)Radiation
All participants received SBRT at 600 cGy x 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Post-Operative Stereotactic Radiosurgery Receives: Radiation: Post-operative, Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Radiographic Recurrence at 12 Months
To estimate the rate of radiographic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Measured: 1 year
Time to Local Recurrence
To estimate the time (in months) to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Measured: 1 year
Secondary outcomes (6)
Number of Participants Receiving Re-treatment
To estimate the rate of re-treatment at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Measured: 1 year
Number of Participants With Symptomatic Recurrence
To estimate the rate of symptomatic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Measured: 1 year
Number of Participants Experiencing Radiation Myelopathy
Number of participants experiencing radiation myelopathy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Measured: 1 year
Number of Participants Experiencing Wound Dehiscence
Number of participants treated with a post-operative stereotactic radiosurgery boost for resected spine metastases, experiencing wound dehiscence.
Measured: 1 year
Time to Return to Chemotherapy
Time in months to return to chemotherapy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Measured: 1 year
Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence
To evaluate the post-treatment symptomatic local recurrence in patients with radio-sensitive tumors.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study start20 May 2013
- Primary completion2 Apr 2018
- Study completion27 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor Spine MetastasesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Post-Operative Stereotactic Radiosurgery
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Redmond, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752036
- Sponsor's protocol ID
- J12133
- Other IDs
- NA_00080433
- Status last verified
- Jun 2020
- First submitted
- 14 Dec 2012
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Redmond KJ, Sciubba D, Khan M, Gui C, Lo SL, Gokaslan ZL, Leaf B, Kleinberg L, Grimm J, Ye X, Lim M. A Phase 2 Study of Post-Operative Stereotactic Body Radiation Therapy (SBRT) for Solid Tumor Spine Metastases. Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):261-268. doi: 10.1016/j.ijrobp.2019.10.011. Epub 2019 Oct 16.
PubMed 31628959
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases
- ClinicalTrials.gov ID
- NCT01752036
- Acronym / sponsor ID
- J12133
- Conditions
- Solid Tumor Spine Metastases
- Keywords
- stereotactic radiotherapy, SRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 20 May 2013 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Posted 25 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. The primary objective of this study is to evaluate radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared to the expected rate following conventional radiation therapy.
Detailed description
This is a phase II trial evaluating the rate radiographic local recurrence following post-operative stereotactic radiosurgery boost in patients with metastatic solid malignancies with spine metastases status post resection. Patients will be treated with 600 cGy x 5 fractions to the tumor bed and then followed both clinically and radiographically to determine if local recurrence following this treatment is better than might be expected for conventional radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Post-Operative Stereotactic Radiosurgery
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Radiation: Post-operative, Stereotactic Body Radiation Therapy (SBRT)Post-Operative Stereotactic Radiosurgery |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥12 years
- Histologically proven solid tumor malignancy with metastasis to the spine. Diagnosis may be acquired from needle biopsy, cytology, or surgical biopsy or resection.
- Radiographic evidence of spinal metastasis is required and may be obtained from plain radiographs, radionuclide bone scans, computed tomography imaging, and magnetic resonance imaging. Other studies may be used with principal investigator approval.
- The patient must have undergone surgical resection resection (gross total, subtotal, or biopsy) of the spinal lesion(s) no more than 12 weeks prior to SRS treatment.
- Treating physician must deem that SRS is appropriate treatment for the metastatic spinal lesion(s).
Key exclusion criteria (5 listed)
- Prior radiation or radiosurgery to the involved level of the spine
- Spine disease from leukemia, lymphoma or myeloma
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 1 year.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
- Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.
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 |
|---|---|---|
| Post-operative, Stereotactic Body Radiation Therapy (SBRT)All participants received SBRT at 600 cGy x 5 fractions | Radiation | Treatment |
Primary outcome
Number of Participants With Radiographic Recurrence at 12 Months
Time frame: 1 year
To estimate the rate of radiographic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Time to Local Recurrence
Time frame: 1 year
To estimate the time (in months) to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
6 secondary outcomes
Number of Participants Receiving Re-treatment
Time frame: 1 year
Number of Participants With Symptomatic Recurrence
Time frame: 1 year
Number of Participants Experiencing Radiation Myelopathy
Time frame: 1 year
Number of Participants Experiencing Wound Dehiscence
Time frame: 1 year
Time to Return to Chemotherapy
Time frame: 1 year
Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31628959Redmond KJ, Sciubba D, Khan M, Gui C, Lo SL, Gokaslan ZL, Leaf B, Kleinberg L, Grimm J, Ye X, Lim M. A Phase 2 Study of Post-Operative Stereotactic Body Radiation Therapy (SBRT) for Solid Tumor Spine Metastases. Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):261-268. doi: 10.1016/j.ijrobp.2019.10.011. Epub 2019 Oct 16.
Related trials for Solid Tumor Spine Metastases
Active, not recruitingPhase 2
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
Spinal Metastases
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Active, not recruitingPhase 2
Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases
Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
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.
Kristin Redmond, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Post-operative, Stereotactic Body Radiation Therapy (SBRT) in people with Solid Tumor Spine Metastases, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 9 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Jun 2020). 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?
Number of Participants With Radiographic Recurrence at 12 Months (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01752036, which also lists 1 linked publication.
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 25 Jun 2020.