Trial Outcomes & Findings for Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival (NCT NCT02364557)

Last Updated: 2025-10-15

Results Overview

Progression (failure) is defined as any of the following: progression of metastases, new metastases, or death. Progression-free survival (PFS) time is defined as time from randomization to the date of first progression, death, or last contact when participant had a documented clinical assessment (censored). PFS rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Median PFS is provided.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

129 participants

Primary outcome timeframe

From randomization to last follow-up. Follow-up schedule: 3 mos after randomization and every 3 months to 24 months, then every six months to five years, then annually. Maximum follow-up at time of analysis was 63 months.

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care (SOC) Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy: Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Overall Study STARTED	68	61
Overall Study Eligible Population	65	60
Overall Study AE Population	62	57
Overall Study Circulating Tumor Cells (CTC) Population	36	26
Overall Study COMPLETED	65	60
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care (SOC) Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy: Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Overall Study Protocol Violation	3	1

Baseline Characteristics

Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care (SOC) n=65 Participants Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation n=60 Participants Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy: Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.	Total n=125 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	55.5 years n=7 Participants	54 years n=5 Participants
Age, Customized ≤ 49 years	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Age, Customized 50-59 years	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Age, Customized 60-69 years	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Age, Customized 70-79 years	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Age, Customized ≥ 80 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	60 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants	45 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Zubrod Performance Status 0	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants
Zubrod Performance Status 1	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) status Positive	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) status Negative	57 Participants n=5 Participants	52 Participants n=7 Participants	109 Participants n=5 Participants
Estrogen Receptor (ER) Status Positive	58 Participants n=5 Participants	51 Participants n=7 Participants	109 Participants n=5 Participants
Estrogen Receptor (ER) Status Negative	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Progesterone Receptor (PR) Status Positive	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Progesterone Receptor (PR) Status Negative	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Hormone Receptor Status ER+ and/or PR+	58 Participants n=5 Participants	54 Participants n=7 Participants	112 Participants n=5 Participants
Hormone Receptor Status ER- and PR-	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Patient Metastasis Count 1	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Patient Metastasis Count >1	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
First-line standard systemic chemotherapy No	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
First-line standard systemic chemotherapy Yes	46 Participants n=5 Participants	44 Participants n=7 Participants	90 Participants n=5 Participants
Timing of the diagnosis of the oligometastatic breast disease relative to the primary breast cancer Synchronous	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Timing of the diagnosis of the oligometastatic breast disease relative to the primary breast cancer Not synchronous	52 Participants n=5 Participants	45 Participants n=7 Participants	97 Participants n=5 Participants
Timing of the diagnosis of the oligometastatic breast disease relative to the primary breast cancer Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to last follow-up. Follow-up schedule: 3 mos after randomization and every 3 months to 24 months, then every six months to five years, then annually. Maximum follow-up at time of analysis was 63 months.

Population: Eligible participants

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=65 Participants Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation n=60 Participants Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy (SBRT): Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Progression-free Survival (Phase II)	23.0 months Interval 18.0 to 29.2	19.5 months Interval 17.0 to 35.6

PRIMARY outcome

Timeframe: From randomization to last follow-up. Follow-up schedule: 3 mos after randomization and every 3 months to 24 months and then annually. Maximum follow-up at time of analysis was 63 months.

Population: It is pre-specified in the study protocol that analysis of Phase III data will not be performed as per the results of the Phase II analysis.

Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization to last follow-up. Follow-up schedule: 3 months after randomization, every 3 months up to 24 months, every six months up to five years, then annually. Maximum follow-up at time of analysis was 63 months. Two-year rates are provide here.

Population: Eligible participants on the SOC + Ablation arm

Metastasis progression (failure) is defined as the clearance and subsequent recurrence or the development of new metastases in the treated area. Failure time is defined as time from randomization to the date of first failure, last contact when participant had a documented clinical assessment (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. Two-year failure rates are provided here.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=60 Participants Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy (SBRT): Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Percentage of Participants With Treated Metastasis Progression on the SOC + Ablation Arm	45.0 percentage of participants Interval 29.8 to 59.1	—

SECONDARY outcome

Population: Eligible participants

New metastases (failure) is defined as the appearance of any new metastases. Failure time is measured from randomization to the date of first failure, last contact when participant had a documented clinical assessment (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year failure rates are provided here

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=65 Participants Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation n=60 Participants Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy (SBRT): Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Percentage of Participants With New Metastases	47.7 percentage of participants Interval 33.9 to 60.2	49.6 percentage of participants Interval 33.9 to 63.5

SECONDARY outcome

Timeframe: From randomization to last follow-up. Follow-up schedule: Arm 1: 3 mos. after randomization / Arm 2: weekly during SBRT and the last day of SBRT; both arms: then every 3 mos. to 24 mos., then annually. Maximum follow-up at time of analysis was 63 months.

Population: Eligible participants who received systemic therapy and/or ablation.

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=62 Participants Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation n=57 Participants Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy (SBRT): Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Number of Patients by Highest Grade Adverse Event Reported Grade 1	7 Participants	15 Participants
Number of Patients by Highest Grade Adverse Event Reported Grade 2	32 Participants	26 Participants
Number of Patients by Highest Grade Adverse Event Reported Grade 3	12 Participants	11 Participants
Number of Patients by Highest Grade Adverse Event Reported Grade 4	4 Participants	0 Participants

SECONDARY outcome

Population: Eligible with blood collection consent and baseline CTC data. The protocol specifies that participants from both treatment arms are combined for this analysis.

The presence of CTCs is defined as ≥ 5 CTCs (per 7.5ml of blood). Progression (failure) is defined as any of the following: progression of metastases, new metastases, or death. Progression-free survival (PFS) time is defined as time from randomization to the date of first progression, death, or last contact when participant had a documented clinical assessment (censored). PFS rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the groups, which is reported in the statistical analysis results. Two-year PFS rates are provided here

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=36 Participants Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation n=26 Participants Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy (SBRT): Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Progression-free Survival in the Presence or Absence of Circulating Tumor Cells (CTCs)	42.3 percentage of participants Interval 24.7 to 59.9	42.3 percentage of participants Interval 21.8 to 62.9

Adverse Events

Standard of Care (Arm 1)

Serious events: 5 serious events

Other events: 55 other events

Deaths: 18 deaths

Standard of Care + Ablation (Arm 2)

Serious events: 2 serious events

Other events: 50 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care (Arm 1) n=62 participants at risk Standard of care systemic therapy at the discretion of the treating physician.	Standard of Care + Ablation (Arm 2) n=57 participants at risk Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Stereotactic Body Radiotherapy: Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy. Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Cardiac disorders Chest pain - cardiac	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	0.00% 0/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Gastrointestinal disorders Ascites	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	0.00% 0/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	0.00% 0/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Hepatobiliary disorders Gallbladder perforation	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	0.00% 0/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Infections and infestations Sepsis	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	0.00% 0/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Infections and infestations Skin infection	0.00% 0/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	1.8% 1/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	1.8% 1/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	1.8% 1/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Musculoskeletal and connective tissue disorders Muscle weakness trunk	0.00% 0/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	1.8% 1/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Renal and urinary disorders Acute kidney injury	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	0.00% 0/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	1.8% 1/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	1.8% 1/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	1.8% 1/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.
Vascular disorders Hot flashes	1.6% 1/62 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.	0.00% 0/57 • From randomization to last follow-up. Follow-up schedule: Arm 1: 3 months after randomization / Arm 2: weekly during SBRT and the last day of SBRT; then every 3 months to 24 months, then annually. Maximum follow-up at time of analysis was 63 months. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who received systemic therapy and/or ablation.

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER