Trial Outcomes & Findings for A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain (NCT NCT00802659)
NCT ID: NCT00802659
Last Updated: 2014-12-05
Results Overview
Optimal dose 1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications 2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
4 weeks
Results posted on
2014-12-05
Participant Flow
Participant milestones
| Measure |
Group -1
1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 1
1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 2
1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 3
1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group -1
1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 1
1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 2
1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 3
1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
Baseline characteristics by cohort
| Measure |
Group -1
1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 1
n=1 Participants
1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 2
1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 3
1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 participants
n=7 Participants
|
—
|
—
|
0 participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 participants
n=7 Participants
|
—
|
—
|
1 participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 participants
n=7 Participants
|
—
|
—
|
0 participants
n=21 Participants
|
|
Gender
Female
|
—
|
1 participants
n=7 Participants
|
—
|
—
|
1 participants
n=21 Participants
|
|
Gender
Male
|
—
|
0 participants
n=7 Participants
|
—
|
—
|
0 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
—
|
—
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
Optimal dose 1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications 2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
A reduction in pain, referable to the site of the spine lesion, by \>=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS) Participant can chose on a scale of 0-4 with 0=not at all and 4=very much.
Outcome measures
Outcome data not reported
Adverse Events
Group -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group -1
1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 1
n=1 participants at risk
1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 2
1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 3
1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Vascular disorders
Hypotension
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
General disorders
Death NOS
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
Other adverse events
| Measure |
Group -1
1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 1
n=1 participants at risk
1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 2
1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
Group 3
1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Blood and lymphatic system disorders
Hemoglobin
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Investigations
Lymphopenia
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Investigations
Platelets
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0
|
100.0%
1/1
|
—
0/0
|
—
0/0
|
Additional Information
Jeffrey Bradley, M.D.
Washington University School of Medicine
Phone: 314-362-8525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place