Trial Outcomes & Findings for Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc (NCT NCT01218542)
NCT ID: NCT01218542
Last Updated: 2021-06-29
Results Overview
The cumulative incidences of recurrence locally and in the whole brain were reported at the patient level.
COMPLETED
NA
22 participants
Locoregional control at 1 year
2021-06-29
Participant Flow
Patients were recruited at Winship Cancer Institute of Emory University from September 2010 to September 2015.
Participant milestones
| Measure |
Volumetric Modulated Arc Therapy
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
|
|---|---|
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Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
13
|
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Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc
Baseline characteristics by cohort
| Measure |
Volumetric Modulated Arc Therapy
n=22 Participants
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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9 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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22 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Locoregional control at 1 yearPopulation: Feasibility by our criteria was met for all participants.
The cumulative incidences of recurrence locally and in the whole brain were reported at the patient level.
Outcome measures
| Measure |
Volumetric Modulated Arc Therapy
n=13 Participants
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
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|---|---|
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Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
1-year Local Control
|
92 percentage of participants
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|
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
Lesion Level Control
|
98.6 percentage of participants
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|
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
1-year Regional Control
|
46 percentage of participants
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Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
Intracranial Control
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46 percentage of participants
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Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
Distant Intracranial Recurrence
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87.5 percentage of participants
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SECONDARY outcome
Timeframe: 11 months median follow up period.Defined as period of time from study entry to to death from any cause or brain tumor recurrence or progression.
Outcome measures
| Measure |
Volumetric Modulated Arc Therapy
n=13 Participants
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
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|---|---|
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Brain Progression-free Survival
|
5.7 months
Interval 2.9 to 26.2
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SECONDARY outcome
Timeframe: 11 months median follow up period.Defined time from study entry to death from any cause.
Outcome measures
| Measure |
Volumetric Modulated Arc Therapy
n=13 Participants
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
|
|---|---|
|
Overall Survival
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8.6 months
Interval 4.1 to 29.6
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SECONDARY outcome
Timeframe: 11 months median follow up period.Neurological test score were assessed using the Hopkins Verbal Learning Test-Revised (HVLT). In the HVLT 12 words are read and the participant is asked to recall them, this is completed 3 times. Total words recalled are summed to give a score for Total Recall (0-36, higher scores demonstrated better recall). Delayed recall is conducted 20-25 minutes later on the same list of 12 words (scored 0-12 with higher scores demonstrating better recall). Retention is calculated as the percent of words recalled (scored 0-100, higher scores representing better recall). Recognition Discrimination is tested by a series of yes/no responses from the participant identifying 12 target words from a list of 24 and calculated by the number of true positives minus the number of true negatives with higher scores indicating a better outcome.
Outcome measures
| Measure |
Volumetric Modulated Arc Therapy
n=13 Participants
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
|
|---|---|
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Neurocognitive Effects
Total Recall
|
1.0 fraction of post-tx over pre-tx scores
Interval 0.73 to 1.27
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Neurocognitive Effects
Delayed Recall
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1.09 fraction of post-tx over pre-tx scores
Interval 0.9 to 1.28
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Neurocognitive Effects
Retention
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0.99 fraction of post-tx over pre-tx scores
Interval 0.72 to 1.258
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Neurocognitive Effects
Recognition Discrimination
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0.96 fraction of post-tx over pre-tx scores
Interval 0.77 to 1.14
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SECONDARY outcome
Timeframe: 11 month median follow upThe Functional Assessment of Cancer Therapy-Brain (FACT-Br) were summed to create the FACT brain trial outcome index (FACT-BR TOI), FACT general (FACT-G), and FACT brain total (FACT-BR Total). Three FACT scales were calculated. The higher the value the better the score, i.e., the better the quality of life perceived by patient. FACT BR TOTAL (FACT-G + BrCS, possible range 0 - 200) FACT-BR TOI (Trial Outcome Index = Physical Well Being \_ Functional Well Being +BrCS, possible range 0 - 148) FACT-G (Fact General, possible range 0 - 108)
Outcome measures
| Measure |
Volumetric Modulated Arc Therapy
n=13 Participants
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
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|---|---|
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Quality of Life as Measured by the FACT-Br Subscales
FACT-BR Total
|
1.0 fraction of post-tx over pre-tx scores
Interval 0.93 to 1.08
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Quality of Life as Measured by the FACT-Br Subscales
FACT-BR TOI
|
0.98 fraction of post-tx over pre-tx scores
Interval 0.87 to 1.081
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Quality of Life as Measured by the FACT-Br Subscales
FACT-G
|
0.98 fraction of post-tx over pre-tx scores
Interval 0.73 to 1.23
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Adverse Events
Volumetric Modulated Arc Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Volumetric Modulated Arc Therapy
n=13 participants at risk
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Volumetric modulated arc therapy: Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
|
|---|---|
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General disorders
Radiation Necrosis
|
15.4%
2/13 • Number of events 2 • Adverse events were collected thorughout the study assessed up to 2 year follow-up
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General disorders
Fatigue
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61.5%
8/13 • Number of events 8 • Adverse events were collected thorughout the study assessed up to 2 year follow-up
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General disorders
Nausea
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38.5%
5/13 • Number of events 5 • Adverse events were collected thorughout the study assessed up to 2 year follow-up
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place