Clinical trial · Interventional
Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
Phase II Protocol Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
NCT02880319CI-TRIAL-00094738active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cancer | Malignant Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Drug | — | UNRESOLVED |
| Stereotactic Linear Accelerator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oligometastatic Disease
- description
- 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
- interventionNames
- Drug: Stereotactic Body Radiation Therapy (SBRT)
- Device: Stereotactic Linear Accelerator
- type
- EXPERIMENTAL
- label
- Re-irradiation to Metastatic Disease
- description
- 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
- interventionNames
- Drug: Stereotactic Body Radiation Therapy (SBRT)
- Device: Stereotactic Linear Accelerator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.