Trial Outcomes & Findings for Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone (NCT NCT02880319)

NCT ID: NCT02880319

Last Updated: 2025-09-09

Results Overview

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.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 150 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-09-09

Participant Flow

Participant milestones

Measure	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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator
Overall Study STARTED	98	44
Overall Study COMPLETED	98	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

Baseline characteristics by cohort

Measure	Oligometastatic Disease n=98 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Re-irradiation to Metastatic Disease n=44 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Total n=142 Participants Total of all reporting groups
Age, Continuous	72 years STANDARD_DEVIATION 10.4 • n=5 Participants	61.5 years STANDARD_DEVIATION 12.7 • n=7 Participants	68.8 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	10 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	34 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	37 Participants n=7 Participants	124 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Oligometastatic Disease n=98 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Re-irradiation to Metastatic Disease n=44 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator
The 6-month Local Control Rate of SBRT	94 Participants	40 Participants

SECONDARY outcome

Timeframe: 1 year

The local progression-free survival is defined as the duration of time from registration to time of local failure or death.

Outcome measures

Measure	Oligometastatic Disease n=98 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Re-irradiation to Metastatic Disease n=44 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator
Number of Participants With 1-year Local Progression-Free Survival	82 Participants	40 Participants

SECONDARY outcome

Timeframe: 2 year

Progression-free survival is defined as the duration of time from registration to time of any progression or death.

Outcome measures

Measure	Oligometastatic Disease n=98 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Re-irradiation to Metastatic Disease n=44 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator
Number of Participants With 2-year Progression-Free Survival	46 Participants	16 Participants

SECONDARY outcome

Timeframe: 2 year

Overall survival is defined as the time between registration and death.

Outcome measures

Measure	Oligometastatic Disease n=98 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Re-irradiation to Metastatic Disease n=44 Participants 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator
2-year Overall Survival Rate	86 Participants	22 Participants

SECONDARY outcome

Timeframe: 3 months

Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Patient reported QOL, symptoms and satisfaction will be assessed using the MDASI general questionnaire at baseline, during treatment and all follow-up visits.

Outcome measures

Outcome data not reported

Adverse Events

Oligometastatic Disease

Serious events: 2 serious events

Other events: 27 other events

Deaths: 28 deaths

Re-irradiation to Metastatic Disease

Serious events: 1 serious events

Other events: 41 other events

Deaths: 29 deaths

Serious adverse events

Measure	Oligometastatic Disease n=98 participants at risk 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Re-irradiation to Metastatic Disease n=44 participants at risk 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator
Cardiac disorders Atrial Fibrillation	1.0% 1/98 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/44 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Hospitalization due to pain at an unrelated metastatic site	0.00% 0/98 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)	2.3% 1/44 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Prolonged hospitalization/Severe esophagitis	1.0% 1/98 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/44 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)

Other adverse events

Measure	Oligometastatic Disease n=98 participants at risk 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator	Re-irradiation to Metastatic Disease n=44 participants at risk 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 Stereotactic Body Radiation Therapy (SBRT) Stereotactic Linear Accelerator
General disorders Fatigue	10.2% 10/98 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)	54.5% 24/44 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Gastrointestinal	15.3% 15/98 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)	25.0% 11/44 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain	7.1% 7/98 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)	63.6% 28/44 • Post-baseline throughout protocol follow-ups. Maximum 5 years. CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)

Additional Information

Dr. Tracy Balboni

DFCI/BWH

Phone: 6177327948

Email: tbalboni@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place