Bone CancerPhase 2NCT02880319
Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and Stereotactic Linear Accelerator in people with Bone Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is studying a form of radiation therapy called stereotactic body radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or other bone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Stereotactic Linear Accelerator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2016to May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both cohorts:
- --≥18 years of age
- ECOG performance status ≤2
- Pathologically proven metastatic solid tumor (non-hematologic malignancy) of the bone (spine or non-spine bone)
- Bony metastatic lesions must be ≤6 cm in maximum dimension and evaluable on either a CT or MRI scan; metastatic lesions in the spine must involve ≤3 contiguous vertebral bodies
- No other active malignancy within the past 2 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix
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- Ability to understand and the willingness to sign a written informed consent document
- Surgery to the lesion in question is allowed if size criteria outlined above are met
- Not currently pregnant or breast feeding
- Cohort 1: Oligometastatic state
- Oligometastatic state is defined by ≤ 3 active sites of disease, including the primary site
- Agreement of both the Chow et al.15 and TEACHH16 models, indicating a median life expectancy of >3 months
- Among patients with multiple sites of metastatic disease, the other sites that will not be treated on this protocol have either been previously treated or are planned for local treatment
- Cohort 2: Re-irradiation
- Previous radiation in the current area of disease requiring radiation
- Life expectancy of >3 months as defined by agreement of both the Chow et al.15 and TEACHH16 models
Who cannot join
- SBRT target size >6 cm in maximum diameter (or >100 cc in volume)
- Hematologic malignancies (including lymphoma, multiple myeloma)
- Prior RT of greater dose intensity than 100 Gy2 based on a biological effective dose (BED) calculation [BED (Gy2) = nd x (1+d/α/ß; where n=number of fractions, d=dose per fraction, α/ß=2)]
- Epidural tumor <2 mm from spinal cord
- Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent hormonal therapies are allowed)
- Inability to lie flat and still for treatment delivery despite anti-anxiety and/or pain medications
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- Non-English speakers are excluded from this study due to use of questionnaires which have not been validated in other languages.
- Patients lacking the capacity to describe their symptoms are excluded as that precludes them (or anyone on their behalf) from filling out the validated questionnaires about symptoms/toxicity.
- Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated within the past 2 years for cervical cancer in situ or basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Protocol Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
This research study is studying a form of radiation therapy called stereotactic body radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or other bone
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating metastases of the bone. "Investigational" means that the intervention is being studied.
SBRT is an advanced technique that allows for more precise delivery of radiation than with standard radiation therapy. In comparison to standard radiation therapy, it allows us to give higher doses of radiation to a tumor while limiting the radiation dose going to the surrounding normal tissues. This technology has been made possible by advances in imaging and treatment capabilities on the radiation treatment machines. SBRT works just as standard radiation therapy works by damaging cancer cells.
SBRT has been used to deliver radiation to people with cancer in the lung and those with metastases in the spine or liver. Studies of those groups have shown low rates of side effects with good rates of killing the cancer in that area and preventing it from coming back. In the current research study, the investigators are looking to further evaluate how well this type of radiation controls disease in bone and whether the toxicity (side effects) of SBRT differs from that of standard treatment. The investigators hypothesis is that toxicity might be less, as less normal tissue receives radiation with SBRT than with standard treatment. It is important to note that SBRT, just like standard radiation therapy for the participant disease, is being used to attempt to stop the growth of cancer cells in a bone metastasis and relieve or prevent any symptoms (ex. pain) associated with bone metastases. The goal of the SBRT is not to cure the participant cancer. The primary goal of the study is to see how well SBRT controls the disease in the bone, and the investigators also want to analyze its ability to control disease symptoms without added toxicity.
- Conditions
- Bone Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Stereotactic Linear Accelerator
- Keywords
- Bone Cancer
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Drug
Stereotactic Linear AcceleratorDevice
| Study group | Role | What they receive |
|---|---|---|
| Oligometastatic Disease | Experimental | Stereotactic Body Radiation Therapy (SBRT)to up to 3 sites of disease occurring in the bone or spine
* Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top.
* Dosage will be determined by physician Receives: Drug: Stereotactic Body Radiation Therapy (SBRT); Device: Stereotactic Linear Accelerator |
| Re-irradiation to Metastatic Disease | Experimental | Stereotactic Body Radiation Therapy (SBRT) to site(s) of disease occurring in the bone or spine
* Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top.
* Dosage will be determined by physician Receives: Drug: Stereotactic Body Radiation Therapy (SBRT); Device: Stereotactic Linear Accelerator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 6-month Local Control Rate of SBRT
The 6-month local control rate is the proportion of patients free of local failure at 6 months after stereotactic body radiation therapy (SBRT). Local failure is defined as the presence of biopsy-proven recurrence or radiologic scans that demonstrate progression at the treated sites.
Measured: 6 months
Secondary outcomes (5)
Number of Participants With 1-year Local Progression-Free Survival
The local progression-free survival is defined as the duration of time from registration to time of local failure or death.
Measured: 1 year
Number of Participants With 2-year Progression-Free Survival
Progression-free survival is defined as the duration of time from registration to time of any progression or death.
Measured: 2 year
2-year Overall Survival Rate
Overall survival is defined as the time between registration and death.
Measured: 2 year
Patient Reported Quality Of Life - Acute
Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.
Measured: 3 months
Patient Reported Quality of Life - Chronic
Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.
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 posted26 Aug 2016 (estimated)
- Study start29 Nov 2016
- Primary completionMay 2022
- Study completionMay 2027 (estimated)
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 Bone CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Balboni, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Tracy Balboni, MD MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880319
- Sponsor's protocol ID
- 16-207
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2016
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Protocol Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
- ClinicalTrials.gov ID
- NCT02880319
- Acronym / sponsor ID
- 16-207
- Conditions
- Bone Cancer
- Keywords
- Bone Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 29 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a form of radiation therapy called stereotactic body radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or other bone
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating metastases of the bone. "Investigational" means that the intervention is being studied.
SBRT is an advanced technique that allows for more precise delivery of radiation than with standard radiation therapy. In comparison to standard radiation therapy, it allows us to give higher doses of radiation to a tumor while limiting the radiation dose going to the surrounding normal tissues. This technology has been made possible by advances in imaging and treatment capabilities on the radiation treatment machines. SBRT works just as standard radiation therapy works by damaging cancer cells.
SBRT has been used to deliver radiation to people with cancer in the lung and those with metastases in the spine or liver. Studies of those groups have shown low rates of side effects with good rates of killing the cancer in that area and preventing it from coming back. In the current research study, the investigators are looking to further evaluate how well this type of radiation controls disease in bone and whether the toxicity (side effects) of SBRT differs from that of standard treatment. The investigators hypothesis is that toxicity might be less, as less normal tissue receives radiation with SBRT than with standard treatment. It is important to note that SBRT, just like standard radiation therapy for the participant disease, is being used to attempt to stop the growth of cancer cells in a bone metastasis and relieve or prevent any symptoms (ex. pain) associated with bone metastases. The goal of the SBRT is not to cure the participant cancer. The primary goal of the study is to see how well SBRT controls the disease in the bone, and the investigators also want to analyze its ability to control disease symptoms without added toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligometastatic Disease | Experimental | Drug: Stereotactic Body Radiation Therapy (SBRT), Device: Stereotactic Linear AcceleratorStereotactic Body Radiation Therapy (SBRT)to up to 3 sites of disease occurring in the bone or spine * Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top. * Dosage will be determined by physician |
| Re-irradiation to Metastatic Disease | Experimental | Drug: Stereotactic Body Radiation Therapy (SBRT), Device: Stereotactic Linear AcceleratorStereotactic Body Radiation Therapy (SBRT) to site(s) of disease occurring in the bone or spine * Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top. * Dosage will be determined by physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Both cohorts:
- --≥18 years of age
- Cohort 1: Oligometastatic state
- Cohort 2: Re-irradiation
Key exclusion criteria (10 listed)
- SBRT target size >6 cm in maximum diameter (or >100 cc in volume)
- Hematologic malignancies (including lymphoma, multiple myeloma)
- Prior RT of greater dose intensity than 100 Gy2 based on a biological effective dose (BED) calculation [BED (Gy2) = nd x (1+d/α/ß; where n=number of fractions, d=dose per fraction, α/ß=2)]
- Epidural tumor <2 mm from spinal cord
- Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent hormonal therapies are allowed)
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Drug | Oligometastatic Disease, Re-irradiation to Metastatic Disease |
| Stereotactic Linear Accelerator | Device | Oligometastatic Disease, Re-irradiation to Metastatic Disease |
Primary outcome
The 6-month Local Control Rate of SBRT
Time frame: 6 months
The 6-month local control rate is the proportion of patients free of local failure at 6 months after stereotactic body radiation therapy (SBRT). Local failure is defined as the presence of biopsy-proven recurrence or radiologic scans that demonstrate progression at the treated sites.
5 secondary outcomes
Number of Participants With 1-year Local Progression-Free Survival
Time frame: 1 year
Number of Participants With 2-year Progression-Free Survival
Time frame: 2 year
2-year Overall Survival Rate
Time frame: 2 year
Patient Reported Quality Of Life - Acute
Time frame: 3 months
Patient Reported Quality of Life - Chronic
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 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Tracy Balboni, MD MPH principal investigator
Dana-Farber Cancer Institute
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 Stereotactic Body Radiation Therapy (SBRT) and Stereotactic Linear Accelerator in people with Bone Cancer, run by Dana-Farber Cancer Institute 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 16 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. 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 29 Aug 2023). 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?
The 6-month Local Control Rate of SBRT (time frame: 6 months). 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 9 Sep 2025.