18 and older, any sex, with Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
In-Brain Distant Failure RatePrimary· 6 Months
An actuarial 6-month rate of new parenchymal lesions seen outside the planning target volume of any lesion that received SIB on any post-treatment MRI (in all 3 planes). This is the binomial proportion of patients who experienced in-brain distant failure by 6 months and the associated 95% confidence interval.
Group
Value
95% CI
Cohort A
0.444
0.137 – 0.788
Treated Lesion Local ControlSecondary· 6 Months
An actuarial 6-month rate of any new, recurrent, or progressing (as defined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria) tumor within the planning target volume on any post-treatment MRI. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last know alive or at the date of death if they expired.
Group
Value
95% CI
Cohort A
1.000
1.000 – 1.000
Overall Survival for Evaluable PatientsSecondary· 6 Months
An actuarial 6-month rate of patients still alive regardless of disease status. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. For patients who expired, the time from treatment start to death was calculated. Patients who did not expire were censored at the date last know alive.
Group
Value
95% CI
Cohort A
1.000
1.000 – 1.000
Change in Neurocognitive Function From Baseline to 6 MonthsSecondary· 6 Months
The change in scores from the neurocognitive test were calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase from baseline and negative values indicate a decrease.
The neurological test scores were assessed with the Hopkins Verbal Learning Test - Revised (HVLT). In the HVLT, 12 nouns are read and the participant is asked to recall in 3 rounds. Total words recalled are summed for the Total Recall score ranging from 0-36 (higher score represents better recall). The delayed recall score is tested 20-25 mins after the initial recall and ranges f
Total Recall Raw Score
Group
Value
95% CI
Cohort A
-1.00
-2.25 – 0.25
Delayed Recall Raw Score
Group
Value
95% CI
Cohort A
-1.00
-2.75 – 0.25
Recognition Discrimination Index Raw Score
Group
Value
95% CI
Cohort A
0.00
-2.75 – 0.00
Change in Health-Related Quality of Life (QoL) From Baseline to 6 MonthsSecondary· 6 Months
The change in scores of health-related quality of life test from baseline to 6 months calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase in score from baseline to 6 months while negative values indicate a decrease.
The Functional Assessment of Cancer Therapy with Brain Subscale (FACT-Br) asks questions on a scale from 0 to 4 with 0 being "not at all" and 4 being "very much". Responses were reversed, if applicable, and compiled to calculate physical well-being (range: 0-28), social/family well-being (range: 0-28), emotional well-being (ran
Physical Well-Being
Group
Value
95% CI
Cohort A
-1.00
-2.00 – 1.00
Social/Family Well-Being
Group
Value
95% CI
Cohort A
-2.00
-2.00 – 1.00
Emotional Well-Being
Group
Value
95% CI
Cohort A
-1.00
-2.00 – 0.00
Functional Well-Being
Group
Value
95% CI
Cohort A
-1.00
-3.00 – 1.00
Bone Marrow Transplant (BMT) Subscale
Group
Value
95% CI
Cohort A
0.00
-3.00 – 2.00
Trial Outcome Index
Group
Value
95% CI
Cohort A
-4.00
-6.00 – 1.00
FACT-G
Group
Value
95% CI
Cohort A
-2.00
-7.00 – 4.00
FACT-BMT
Group
Value
95% CI
Cohort A
-1.00
-8.00 – 3.83
Change in Performance StatusSecondary· 12 Months
Total change in performance status score was calculated by substracting the baseline score from the follow-up score. Positive values indicate an increase in score from baseline while negative values indicate a decrease in score from baseline. Functional status evaluated using the Karnofsky Performance Score (KPS) Index. The KPS score is evaluated on a scale from 0 to 100 where 0 is death and 100 is "normal no complaints; no evidence of disease".
Baseline to 3 Months
Group
Value
95% CI
Cohort A
-10.00
-10.00 – 10.00
Baseline to 6 Months
Group
Value
95% CI
Cohort A
0.00
0.00 – 0.00
Baseline to 12 Months
Group
Value
95% CI
Cohort A
0.00
0.00 – 5.00
Incidence of Early and Late Treatment-Related Adverse EffectsSecondary· Up To 39 Months
This is the percentage of eligible patients who experienced the respective treatment-related AE while on study. Adverse effects (AEs) were defined per CTCAE and considered treatment-related if the AE start date occurred on or after the first date of treatment and it was possibly, probably, or definitely related to treatment. AEs were recorded from the start of treatment until the patient was off-study.
Fatigue
Group
Value
95% CI
Cohort A
50.00
Alopecia
Group
Value
95% CI
Cohort A
30.00
Memory Impairment
Group
Value
95% CI
Cohort A
25.00
Headache
Group
Value
95% CI
Cohort A
10.00
Somnolence
Group
Value
95% CI
Cohort A
10.00
Blurred Vision
Group
Value
95% CI
Cohort A
5.00
Cognitive Disturbance
Group
Value
95% CI
Cohort A
5.00
Dermatitis Radiation
Group
Value
95% CI
Cohort A
5.00
Overall Survival for Eligible PatientsSecondary· 6 Months
An actuarial 6-month rate of patients still alive regardless of disease status. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. For patients who expired, the time from treatment start to death was calculated. Patients who did not expire were censored at the date last know alive.
Group
Value
95% CI
Cohort A
0.700
0.451 – 0.853
Change in Neurocognitive Function Retention Percentage Raw Score From Baseline to 6 MonthsSecondary· 6 Months
The change in scores from the neurocognitive test were calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase from baseline and negative values indicate a decrease.
The neurological test scores were assessed with the Hopkins Verbal Learning Test - Revised (HVLT). In the HVLT, 12 nouns are read and the participant is asked to recall in 3 rounds. Total words recalled are summed for the Total Recall score ranging from 0-36 (higher score represents better recall). The delayed recall score is tested 20-25 mins after the initial recall and ranges f
Group
Value
95% CI
Cohort A
-3.00
-30.50 – 2.25
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected throughout the study and assessed up to 39 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This trial is a pilot, Phase 2, sequential two-cohort study designed to test two de-escalated whole brain radiation therapy (WBRT) dose levels and assess their ability to maintain acceptable in-brain distant control. The WBRT dose would decrease as the study moves forward, both in terms of absolute value and equivalent dose in 2 Gray fractions (EQD2) (as determined by the linear quadratic radiobiological model). The absolute value of the simultaneous integrated boost (SIB) dose will change with each dose level because the number of fractions delivered will depend on the WBRT dose. As such, the SIB dose will be manipulated such that the EQD2 will remain essentially equivalent despite the difference in the number of fractions delivered. This design will ensure that the only variable is the change in WBRT dose.
The concept is that WBRT with SIB would be expected to maximize both local and in-brain distant control as has already been shown in studies exploring WBRT with SRS boost. However, by itself WBRT with SIB does not address the concern over neurocognitive outcomes. Therefore, investigators hypothesize that there is a lower WBRT dose threshold that will maintain acceptable in-brain distant control, particularly in the setting of a SIB to gross lesions to maintain treated lesion control. In addition, lower overall brain dose (including lower hippocampal dose without specific hippocampal avoidance) may potentially improve neurocognitive function. Investigators are also interested in evaluating treated lesion control, overall survival, neurocognitive sequelae of therapy, quality of life, performance status, and adverse effects of therapy. Biomarker identification for potential correlative circulating tumor DNA and microRNA is an exploratory endpoint to generate data for future prospective evaluation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 28 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03189381.