Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute

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.