Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
Condition: Bone Cancer
MeSH terms: Bone Neoplasms; Osteosarcoma; Bone Diseases
Intervention: Stereotactic Body Radiation Therapy (SBRT); Stereotactic Linear Accelerator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone Cancer

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
    

Eligibility criteria:

        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.