Trial Outcomes & Findings for SBRT + PD-1/PDL-1 Inhibiting Therapy for Advanced Solid Tumors After Dz Control on PD-1/PDL-1 Tx (NCT NCT03220854)
NCT ID: NCT03220854
Last Updated: 2022-01-10
Results Overview
1. Number of patients with improved disease control at 24 weeks following RT \[Time Frame: up to 24 weeks following RT\] 1a. Number of participants with improved disease control (SD, PR or CR) at 24 weeks per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 1b. For participants enrolled with brain metastases: number of participants with improved disease (SD, PR or CR) control at 24 weeks per per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 24 weeks following SRT
Results posted on
2022-01-10
Participant Flow
No participants enrolled in Arm B.
Participant milestones
| Measure |
A: Patients Receiving SBRT (Body) Irradiation Only
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
|
C: Patients Receiving SRS (Brain) Irradiation Only
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
1
|
|
Overall Study
COMPLETED
|
4
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SBRT + PD-1/PDL-1 Inhibiting Therapy for Advanced Solid Tumors After Dz Control on PD-1/PDL-1 Tx
Baseline characteristics by cohort
| Measure |
A: Patients Receiving SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
—
|
67 years
n=5 Participants
|
67.8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks following SRTPopulation: No participants enrolled in Arm B
1. Number of patients with improved disease control at 24 weeks following RT \[Time Frame: up to 24 weeks following RT\] 1a. Number of participants with improved disease control (SD, PR or CR) at 24 weeks per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 1b. For participants enrolled with brain metastases: number of participants with improved disease (SD, PR or CR) control at 24 weeks per per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM)
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Number of Patients With Improved Disease Control
1a: Number of participants with improved disease control · Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Improved Disease Control
1a: Number of participants with improved disease control · Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Improved Disease Control
1a: Number of participants with improved disease control · Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Improved Disease Control
1a: Number of participants with improved disease control · Progression at or before 24 Weeks
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Improved Disease Control
1a: Number of participants with improved disease control · Not Evaluable
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Improved Disease Control
1b: Participants enrolled with brain metastases number of participants with improved disease control · Complete Response
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
0 Participants
|
|
Number of Patients With Improved Disease Control
1b: Participants enrolled with brain metastases number of participants with improved disease control · Partial Response
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
0 Participants
|
|
Number of Patients With Improved Disease Control
1b: Participants enrolled with brain metastases number of participants with improved disease control · Stable Disease
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
1 Participants
|
|
Number of Patients With Improved Disease Control
1b: Participants enrolled with brain metastases number of participants with improved disease control · Progression at or before 24 Weeks
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
0 Participants
|
|
Number of Patients With Improved Disease Control
1b: Participants enrolled with brain metastases number of participants with improved disease control · Not Evaluable
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks following SRTPopulation: No participants were enrolled in Arm B
Number of participants alive and without progression (irSD+irPR+irCR) at 24 weeks post-RT per unidimensional immune-related response criteria (irRC) 1b. For participants enrolled with brain metastases: number of participants alive and without progression (SD+PR+CR) at 24 weeks post-RT per immune Response Assessment in Neuro-Oncology (iRANO)
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
1a. Number of participants alive and without progression · Progression Free Survival per irRC at 24 wks
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
1a. Number of participants alive and without progression · Progression per irRC at or before 24 Weeks
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
1a. Number of participants alive and without progression · Not Evaluable
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
1b.For participants enrolled with brain metastases · Progression Free Survival per irRC at 24 wks
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
1 Participants
|
|
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
1b.For participants enrolled with brain metastases · Progression per irRC at or before 24 Weeks
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
0 Participants
|
|
Number of Patients Alive and Free From Progression at 24 Weeks Following SRT Per Unidimensional Immune-related Response Criteria (irRC)
1b.For participants enrolled with brain metastases · Not Evaluable
|
NA Participants
Group A participants did not receive brain irradiation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks following SRTPopulation: No participants enrolled on Arm B.
Number of participants with treatment response in irradiated tumor sites at 24 weeks post-RT.
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Number of Participants With Treatment Response in Irradiated Tumor Sites
Complete Response at Irradiated Sites
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Treatment Response in Irradiated Tumor Sites
Partial Response at Irradiated Sites
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Treatment Response in Irradiated Tumor Sites
Stable Disease at Irradiated Sites
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Treatment Response in Irradiated Tumor Sites
Not assessed at week 24 due to overall progression
|
2 Participants
|
—
|
0 Participants
|
|
Number of Participants With Treatment Response in Irradiated Tumor Sites
Not Evaluable
|
2 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks post-RTPopulation: No participants enrolled on Arm B
Number of participants with treatment response in non-irradiated tumor sites at 24 weeks post-RT
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Number of Participants With Treatment Response in Non-irradiated Tumor Sites
Complete Response at non-irradiated sites
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Treatment Response in Non-irradiated Tumor Sites
Partial Response at non-irradiated sites
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Treatment Response in Non-irradiated Tumor Sites
Stable Disease at non-irradiated sites
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Treatment Response in Non-irradiated Tumor Sites
Progression at non-irradiated sites at or before 24 weeks
|
2 Participants
|
—
|
1 Participants
|
|
Number of Participants With Treatment Response in Non-irradiated Tumor Sites
Not Evaluable
|
2 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 years following SRTPopulation: No participants enrolled on Arm B
Number of patients who are alive at 2 years after completion of SRT
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Number of Patients Alive
Number of participants meeting 2 year survival threshold
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Alive
Number of participants not meeting 2 year survival threshold
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Alive
Not evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 8 weeks following SRTPopulation: No participants enrolled in Arm B
Number of participants with grade 3 or greater toxicity from the regimen through 8 weeks following RT
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Number of Participants With Grade 3 or Greater Toxicity
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years following RTPopulation: No participants enrolled on Arm B
Number participants with immune-related AEs (irAEs) that require both checkpoint-inhibitor discontinuation and initiation of steroids reported per CTCAE v5.0
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Number of Participants With Immune-related Toxicity From the Regimen
Participants with immune-related AEs (irAEs)
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants With Immune-related Toxicity From the Regimen
Participants with no immune related AE's (irAEs)
|
2 Participants
|
—
|
1 Participants
|
|
Number of Participants With Immune-related Toxicity From the Regimen
Not Evaluable
|
1 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeks post SRTPopulation: No participants enrolled on Arm B
Number participants with samples collected and number of participants with samples analyzed for immunologic effects of the regimen
Outcome measures
| Measure |
A: SBRT (Body) Irradiation Only
n=4 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 Participants
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
|---|---|---|---|
|
Radiobiological Signatures Associated With the Regimen
Number of participants with samples collected
|
3 Participants
|
—
|
1 Participants
|
|
Radiobiological Signatures Associated With the Regimen
Number of participants with samples analyzed for immunologic effects of the regimen
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radiobiological Signatures Associated With the Regimen
Number of participants with no samples collected
|
1 Participants
|
—
|
0 Participants
|
Adverse Events
A: Patients Receiving SBRT (Body) Irradiation Only
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C: Patients Receiving SRS (Brain) Irradiation Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A: Patients Receiving SBRT (Body) Irradiation Only
n=4 participants at risk
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
|
B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
|
C: Patients Receiving SRS (Brain) Irradiation Only
n=1 participants at risk
Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
|
|---|---|---|---|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
1/4 • Number of events 1 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
—
0/0 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
0.00%
0/1 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
—
0/0 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
0.00%
0/1 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
|
Investigations
Lymphocyte Count Decreased
|
25.0%
1/4 • Number of events 1 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
—
0/0 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
|
0.00%
0/1 • Adverse Event data was collected from the time of first SRT fraction and continued until 8 weeks following completion of SRT.
There were no participants enrolled on Arm B.
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Additional Information
Alfredo I Urdaneta
Virginia Commonwealth University Massey Cancer Center
Phone: (804) 828-0450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place