Trial Outcomes & Findings for Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain (NCT NCT03523351)
NCT ID: NCT03523351
Last Updated: 2025-04-20
Results Overview
which will be defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
1 year
Results posted on
2025-04-20
Participant Flow
Participant milestones
| Measure |
Standard of Care
Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).
Systemic Therapy: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
|
Selective Radiation to ≤5 Highest Risk Bone Metastases
Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.
Radiation Therapy: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
19
|
16
|
Reasons for withdrawal
| Measure |
Standard of Care
Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).
Systemic Therapy: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
|
Selective Radiation to ≤5 Highest Risk Bone Metastases
Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.
Radiation Therapy: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
|
|---|---|---|
|
Overall Study
Death
|
13
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Patient was not treated on study but enrolled due to progressive disease during active treatment
|
0
|
2
|
Baseline Characteristics
Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain
Baseline characteristics by cohort
| Measure |
Standard of Care
n=39 Participants
Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).
Systemic Therapy: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
|
Selective Radiation to ≤5 Highest Risk Bone Metastases
n=39 Participants
Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.
Radiation Therapy: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=93 Participants
|
58 years
n=4 Participants
|
58 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearwhich will be defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.
Outcome measures
| Measure |
Standard of Care
n=39 Participants
Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).
Systemic Therapy: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
|
Selective Radiation to ≤5 Highest Risk Bone Metastases
n=39 Participants
Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.
Radiation Therapy: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
|
|---|---|---|
|
Number of Participants With Skeletal Related Events (SREs)
Skeletal Related Events
|
10 number of participants
|
1 number of participants
|
|
Number of Participants With Skeletal Related Events (SREs)
No Skeletal Related Events
|
29 number of participants
|
38 number of participants
|
Adverse Events
Standard of Care
Serious events: 4 serious events
Other events: 34 other events
Deaths: 28 deaths
Selective Radiation to ≤5 Highest Risk Bone Metastases
Serious events: 2 serious events
Other events: 35 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Standard of Care
n=39 participants at risk
Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).
Systemic Therapy: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
|
Selective Radiation to ≤5 Highest Risk Bone Metastases
n=39 participants at risk
Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.
Radiation Therapy: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/39 • 2 years
|
2.6%
1/39 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Gastrointestinal disorders
Esophageal varices
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/39 • 2 years
|
2.6%
1/39 • 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Investigations
Neutrophil count decrease
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
Other adverse events
| Measure |
Standard of Care
n=39 participants at risk
Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).
Systemic Therapy: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
|
Selective Radiation to ≤5 Highest Risk Bone Metastases
n=39 participants at risk
Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.
Radiation Therapy: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
71.8%
28/39 • 2 years
|
66.7%
26/39 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/39 • 2 years
|
2.6%
1/39 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • 2 years
|
2.6%
1/39 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.3%
4/39 • 2 years
|
10.3%
4/39 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
0.00%
0/39 • 2 years
|
2.6%
1/39 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
4/39 • 2 years
|
20.5%
8/39 • 2 years
|
|
General disorders
Fatigue
|
28.2%
11/39 • 2 years
|
56.4%
22/39 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.1%
9/39 • 2 years
|
17.9%
7/39 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
56.4%
22/39 • 2 years
|
61.5%
24/39 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • 2 years
|
17.9%
7/39 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Investigations
Neutrophil count decreased
|
12.8%
5/39 • 2 years
|
15.4%
6/39 • 2 years
|
|
General disorders
Pain
|
12.8%
5/39 • 2 years
|
15.4%
6/39 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.6%
1/39 • 2 years
|
0.00%
0/39 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.1%
2/39 • 2 years
|
2.6%
1/39 • 2 years
|
|
Investigations
Platelet count decreased
|
25.6%
10/39 • 2 years
|
25.6%
10/39 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • 2 years
|
5.1%
2/39 • 2 years
|
|
Investigations
White blood cell decreased
|
30.8%
12/39 • 2 years
|
28.2%
11/39 • 2 years
|
Additional Information
Dr. Divya Yerramilli, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-449-1931
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place