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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Locoregional control at 1 year

Results posted on

2021-06-29

Participant Flow

Patients were recruited at Winship Cancer Institute of Emory University from September 2010 to September 2015.

Participant milestones

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.
Overall Study
STARTED
22
Overall Study
COMPLETED
13
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

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.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
n=99 Participants
Age, Categorical
>=65 years
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
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
Region of Enrollment
United States
22 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Locoregional control at 1 year

Population: 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

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.
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
1-year Local Control
92 percentage of participants
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
Lesion Level Control
98.6 percentage of participants
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
1-year Regional Control
46 percentage of participants
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
Intracranial Control
46 percentage of participants
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
Distant Intracranial Recurrence
87.5 percentage of participants

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

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.
Brain Progression-free Survival
5.7 months
Interval 2.9 to 26.2

SECONDARY outcome

Timeframe: 11 months median follow up period.

Defined time from study entry to death from any cause.

Outcome measures

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
8.6 months
Interval 4.1 to 29.6

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

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.
Neurocognitive Effects
Total Recall
1.0 fraction of post-tx over pre-tx scores
Interval 0.73 to 1.27
Neurocognitive Effects
Delayed Recall
1.09 fraction of post-tx over pre-tx scores
Interval 0.9 to 1.28
Neurocognitive Effects
Retention
0.99 fraction of post-tx over pre-tx scores
Interval 0.72 to 1.258
Neurocognitive Effects
Recognition Discrimination
0.96 fraction of post-tx over pre-tx scores
Interval 0.77 to 1.14

SECONDARY outcome

Timeframe: 11 month median follow up

The 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

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.
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
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
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

Adverse Events

Volumetric Modulated Arc Therapy

Serious events: 0 serious events
Other events: 13 other events
Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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.
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
General disorders
Fatigue
61.5%
8/13 • Number of events 8 • Adverse events were collected thorughout the study assessed up to 2 year follow-up
General disorders
Nausea
38.5%
5/13 • Number of events 5 • Adverse events were collected thorughout the study assessed up to 2 year follow-up

Additional Information

Dr. Hui-Kuo Shu

Emory University

Phone: 404-778-2161

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place