Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone
- Conditions
- Bone Cancer
- Registration Number
- NCT02880319
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria:<br><br> - Both cohorts:<br><br> --=18 years of age<br><br> - ECOG performance status =2<br><br> - Pathologically proven metastatic solid tumor (non-hematologic malignancy) of<br> the bone (spine or non-spine bone)<br><br> - Bony metastatic lesions must be =6 cm in maximum dimension and evaluable on<br> either a CT or MRI scan; metastatic lesions in the spine must involve =3<br> contiguous vertebral bodies<br><br> - No other active malignancy within the past 2 years, except for non-melanoma<br> skin cancers or carcinoma in situ of the cervix<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document<br><br> - Surgery to the lesion in question is allowed if size criteria outlined above<br> are met<br><br> - Not currently pregnant or breast feeding<br><br> - Cohort 1: Oligometastatic state<br><br> - Oligometastatic state is defined by = 3 active sites of disease, including the<br> primary site<br><br> - Agreement of both the Chow et al.15 and TEACHH16 models, indicating a median<br> life expectancy of >3 months<br><br> - Among patients with multiple sites of metastatic disease, the other sites that<br> will not be treated on this protocol have either been previously treated or are<br> planned for local treatment<br><br> - Cohort 2: Re-irradiation<br><br> - Previous radiation in the current area of disease requiring radiation<br><br> - Life expectancy of >3 months as defined by agreement of both the Chow et al.15<br> and TEACHH16 models<br><br>Exclusion Criteria:<br><br> - SBRT target size >6 cm in maximum diameter (or >100 cc in volume)<br><br> - Hematologic malignancies (including lymphoma, multiple myeloma)<br><br> - Prior RT of greater dose intensity than 100 Gy2 based on a biological effective dose<br> (BED) calculation [BED (Gy2) = nd x (1+d/a/ß; where n=number of fractions, d=dose<br> per fraction, a/ß=2)]<br><br> - Epidural tumor <2 mm from spinal cord<br><br> - Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent<br> hormonal therapies are allowed)<br><br> - Inability to lie flat and still for treatment delivery despite anti-anxiety and/or<br> pain medications<br><br> - Non-English speakers are excluded from this study due to use of questionnaires which<br> have not been validated in other languages.<br><br> - Patients lacking the capacity to describe their symptoms are excluded as that<br> precludes them (or anyone on their behalf) from filling out the validated<br> questionnaires about symptoms/toxicity.<br><br> - Pregnant women are excluded from this study because radiotherapy has the potential<br> for teratogenic or abortifacient effects.<br><br> - Individuals with a history of a different malignancy are ineligible except for the<br> following circumstances: if they have been disease-free for at least 2 years and are<br> deemed by the investigator to be at low risk for recurrence of that malignancy; or<br> if diagnosed and treated within the past 2 years for cervical cancer in situ or<br> basal cell or squamous cell carcinoma of the skin.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 6-month Local Control Rate of SBRT
- Secondary Outcome Measures
Name Time Method Number of Participants With 1-year Local Progression-Free Survival;Number of Participants With 2-year Progression-Free Survival;2-year Overall Survival Rate;Patient Reported Quality Of Life - Acute;Patient Reported Quality of Life - Chronic