Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

NCT02880319 | Active Not Recruiting Phase 2 Results DMC

• 1 other identifier: 16-207
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bone Cancer

Keywords

Bone Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Number of Participants With 1-year Local Progression-Free Survival

  1 year

• Number of Participants With 2-year Progression-Free Survival

  2 year

• 2-year Overall Survival Rate

  2 year

• Patient Reported Quality Of Life - Acute

  3 months

• Patient Reported Quality of Life - Chronic

  1 year

Study Arms (2)

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

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

Drug: Stereotactic Body Radiation Therapy (SBRT); Device: Stereotactic Linear Accelerator

Interventions

Stereotactic Body Radiation Therapy (SBRT) DRUG

Oligometastatic Disease; Re-irradiation to Metastatic Disease

Stereotactic Linear Accelerator DEVICE

Oligometastatic Disease; Re-irradiation to Metastatic Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Tracy Balboni
• Organization: DFCI/BWH

tbalboni@bwh.harvard.edu

6177327948

Study Officials

• Tracy Balboni, MD MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tracy Balboni, MD, MPH

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: November 29, 2016
• Primary Completion: May 1, 2022
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 9, 2025
• Results First Posted: August 29, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)