Trial Outcomes & Findings for Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection (NCT NCT04040400)
NCT ID: NCT04040400
Last Updated: 2023-10-12
Results Overview
Maximum tolerated dose will be determined by classical 3+3 dose-escalation design. Toxicity will be measured using the National Cancer Institute Common terminology criteria for adverse events (version 5.0). The first dose of 18Gy will be administered to the first 3 subjects, after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if the next 3 subject will escalation to dose of 21Gy or receive 18Gy. If escalation to 21Gy is permitted, then after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if next cohort of 3 subjects will escalate to a dose of 24Gy or receive 21Gy. The highest dose level to be administered will be 24 Gy if permitted by safety assessments.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Phase I cohorts; 90 days from treatments
Results posted on
2023-10-12
Participant Flow
Participant milestones
| Measure |
Treatment Arm Intraoperative Radiotherapy (IORT)
Cohort 1 received 18 Gy. Intraoperative radiotherapy (IORT) during brain tumor resection.
|
Cohort 2
Planned dose: 21 Gy. No patient accrued in this cohort.
|
Cohort 3
Planned dosage 24 Gy. No patient accrued in this cohort.
|
|---|---|---|---|
|
Cohort 1
STARTED
|
5
|
0
|
0
|
|
Cohort 1
COMPLETED
|
5
|
0
|
0
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort 1:
STARTED
|
5
|
0
|
0
|
|
Cohort 1:
COMPLETED
|
4
|
0
|
0
|
|
Cohort 1:
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 screen failed and 1 withdrew and were unable to be analyzed.
Baseline characteristics by cohort
| Measure |
Intraoperative Radiotherapy Treatment Arm
n=5 Participants
Participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 3 screen failed and 1 withdrew and were unable to be analyzed.
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants • 3 screen failed and 1 withdrew and were unable to be analyzed.
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants • 3 screen failed and 1 withdrew and were unable to be analyzed.
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants • 3 screen failed and 1 withdrew and were not analyzed.
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants • 3 screen failed and 1 withdrew and were not analyzed.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase I cohorts; 90 days from treatmentsMaximum tolerated dose will be determined by classical 3+3 dose-escalation design. Toxicity will be measured using the National Cancer Institute Common terminology criteria for adverse events (version 5.0). The first dose of 18Gy will be administered to the first 3 subjects, after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if the next 3 subject will escalation to dose of 21Gy or receive 18Gy. If escalation to 21Gy is permitted, then after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if next cohort of 3 subjects will escalate to a dose of 24Gy or receive 21Gy. The highest dose level to be administered will be 24 Gy if permitted by safety assessments.
Outcome measures
| Measure |
IORT Treatment Arm
n=5 Participants
Participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
|---|---|
|
Established Maximum Tolerated Dose
18 Gy
|
5 Participants
|
|
Established Maximum Tolerated Dose
21 Gy
|
0 Participants
|
|
Established Maximum Tolerated Dose
24 Gy
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: participants that received intraoperative radiation.
Number of adverse events reported per participant.
Outcome measures
| Measure |
IORT Treatment Arm
n=5 Participants
Participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
|---|---|
|
Number of Participants With Adverse Events
|
5 participants
|
Adverse Events
Cohort 1: 18 Gy
Serious events: 5 serious events
Other events: 1 other events
Deaths: 4 deaths
Cohort 2: 21 Gy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: 24 Gy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 18 Gy
n=5 participants at risk
Participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
Cohort 2: 21 Gy
Planned participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
Cohort 3: 24 Gy
Planned participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
|
Renal and urinary disorders
Acute Kidney Injufy
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Worsening Malignancy
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
|
Blood and lymphatic system disorders
Thromboembolic Event
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
|
Infections and infestations
Meningitis - Bacterial
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
|
Nervous system disorders
Altered Mental Status
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
Other adverse events
| Measure |
Cohort 1: 18 Gy
n=5 participants at risk
Participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
Cohort 2: 21 Gy
Planned participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
Cohort 3: 24 Gy
Planned participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.
|
|---|---|---|---|
|
General disorders
XOft Overdose
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Worsening Malignancy
|
20.0%
1/5 • Number of events 1 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
—
0/0 • Adverse Event data was collected from date of first patient enrollment to close of study due to all participant death/loss to follow-up, a period of 2 years from study activation.
Zero participants accrued in cohorts 2 and 3.
|
Additional Information
Shiao Woo, MD Principal Investigator
University of Louisville Brown Cancer Center
Phone: 502-562-4360
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place