NCT04040400

Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection

Terminated NA Results posted Last updated 12 October 2023

What this trial tests

NA trial testing intraoperative radiotherapy (IORT) in Brain Metastases in 5 participants. Terminated before completion.

Timeline

23 October 2019

Primary endpoint
19 November 2021

19 November 2021

Quick facts

Lead sponsor	University of Louisville
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	23 October 2019
Primary completion	19 November 2021
Estimated completion	19 November 2021
Sites	1 location across United States

Drugs / interventions tested

• intraoperative radiotherapy (IORT)

Conditions studied

• Brain Metastases — all drugs for Brain Metastases →

Sponsor

University of Louisville

Who can join

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.

Established Maximum Tolerated Dose Primary · Phase I cohorts; 90 days from treatments

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

18 Gy

Group	Value	95% CI
IORT Treatment Arm	5

21 Gy

Group	Value	95% CI
IORT Treatment Arm	0

24 Gy

Group	Value	95% CI
IORT Treatment Arm	0

Number of Participants With Adverse Events Primary · 12 months

Number of adverse events reported per participant.

Group	Value	95% CI
IORT Treatment Arm	5

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: 18 Gy

Serious: 5/5 (100%)

Deaths: 4/5

Cohort 2: 21 Gy

Serious: 0

Deaths: 0

Cohort 3: 24 Gy

Serious: 0

Deaths: 0

Serious adverse events (6 terms)

Reaction	System	Cohort 1: 18 Gy	Cohort 2: 21 Gy	Cohort 3: 24 Gy
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Acute Kidney Injufy	Renal and urinary disorders	—	—	—
Worsening Malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Thromboembolic Event	Blood and lymphatic system disorders	—	—	—
Meningitis - Bacterial	Infections and infestations	—	—	—
Altered Mental Status	Nervous system disorders	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Cohort 1: 18 Gy	Cohort 2: 21 Gy	Cohort 3: 24 Gy
XOft Overdose	General disorders	—	—	—
Worsening Malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Most-reported serious reactions: Respiratory Failure, Acute Kidney Injufy, Worsening Malignancy, Thromboembolic Event, Meningitis - Bacterial, Altered Mental Status.

Data from ClinicalTrials.gov NCT04040400 adverse events section.

Sponsor's own description

The primary purpose of this study is to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT) following neurosurgical resection for large brain metastases, and to determine the progression-free survival rate as in the recurrence rate of treated brain metastasis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.