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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Cancer
• Intervention / Treatment: Drug: Stereotactic Body Radiation Therapy (SBRT); Device: Stereotactic Linear Accelerator

Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating metastases of the bone. "Investigational" means that the intervention is being studied.

SBRT is an advanced technique that allows for more precise delivery of radiation than with standard radiation therapy. In comparison to standard radiation therapy, it allows us to give higher doses of radiation to a tumor while limiting the radiation dose going to the surrounding normal tissues. This technology has been made possible by advances in imaging and treatment capabilities on the radiation treatment machines. SBRT works just as standard radiation therapy works by damaging cancer cells.

SBRT has been used to deliver radiation to people with cancer in the lung and those with metastases in the spine or liver. Studies of those groups have shown low rates of side effects with good rates of killing the cancer in that area and preventing it from coming back. In the current research study, the investigators are looking to further evaluate how well this type of radiation controls disease in bone and whether the toxicity (side effects) of SBRT differs from that of standard treatment. The investigators hypothesis is that toxicity might be less, as less normal tissue receives radiation with SBRT than with standard treatment. It is important to note that SBRT, just like standard radiation therapy for the participant disease, is being used to attempt to stop the growth of cancer cells in a bone metastasis and relieve or prevent any symptoms (ex. pain) associated with bone metastases. The goal of the SBRT is not to cure the participant cancer. The primary goal of the study is to see how well SBRT controls the disease in the bone, and the investigators also want to analyze its ability to control disease symptoms without added toxicity.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oligometastatic Disease; 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
Experimental: Re-irradiation to Metastatic Disease; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Quality Of Life - Acute	Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.	3 months
Patient Reported Quality of Life - Chronic	Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.	1 year
Number of Participants With 1-year Local Progression-Free Survival	The local progression-free survival is defined as the duration of time from registration to time of local failure or death.	1 year
Number of Participants With 2-year Progression-Free Survival	Progression-free survival is defined as the duration of time from registration to time of any progression or death.	2 year
2-year Overall Survival Rate	Overall survival is defined as the time between registration and death.	2 year

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Tracy Balboni, MD MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): May 1, 2022
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimated): August 26, 2016

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Bone Cancer
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 16-207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO