Brain MetastasesNCT04040400

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

A study testing intraoperative radiotherapy (IORT) in people with Brain Metastases, run by University of Louisville at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Metastases
What is being tested?: intraoperative radiotherapy (IORT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2019to 19 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must be ≥ 18 years of age.
Participants must have a Karnosfky performance status of ≥ 50%.
Participants must not have had prior intracranial radiation.
Participants must have a life expectancy greater than 3 months.
Participants must have a preoperative MRI Brain T1-Gadolinum enhanced scan demonstrating a non-dural based lesion with greatest diameter ≥ 2.5 cm.
Sufficient distance (≥ 2cm) of the intracranial lesion from optic structures (optic chiasm and bilateral optic nerves) and brainstem to meet established normal structure dose limits.

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Subject or subject's legal representative to provide signed/written informed consent to participate in the study protocol.
Surface of balloon applicator must be ≥ 1cm from skin overlying closest portion of calvarium.
Participants may remain on systemic therapy if they are receiving immunotherapy (anti-PD1, anti-PDL1, anti-CTLA-4), capecitabine, temozolomide, etoposide, vinorelbine, pemetrexed, lapatinib, traztuzumab, bevacizumab, mTor or ALK targeted agents with no break prior to initiating IORT.
9.1 Participants receiving cisplatin, methotrexate, taxanes, tyrosine kinase inhibitors, or BRAF targeted agents must have a seven day washout period prior to receiving IORT.
9.2 Participants receiving doxorubicin, T-DM1, or antibody-drug conjugates must have a fourteen day washout period prior to receiving IORT.
9.3. Participants receiving all other concurrent systemic agents will undergo consideration for a washout period prior to receiving IORT at the discretion of the study principal investigator.

Who cannot join

Participants may not be pregnant or breast-feeding.
Patients must not have dural lesions or leptomeningeal disease.
Patients must not have psychiatric or social conditions limiting adherence to protocol guidelines.
Patients must not have contraindications to anesthesia, surgery, or MR imaging with Gadolinium injection.
Patients must not have a frozen section diagnosis of small cell carcinoma, lymphoma, germinoma or non-malignant histology.
Patients with additional unresected brain metastases must have a limited number of lesions/or volume of intracranial disease amenable to stereotactic radiotherapy at the discretion of the study principal investigator.
Patients deemed to require postoperative whole brain radiotherapy should be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: A Phase I/II Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection

Read the detailed description

The potential for delivering ablative doses of radiation to the tumor bed while simultaneously sparing normal brain parenchyma from significant doses of radiation and reducing the potential for tumor repopulation has led to interest in the use of intraoperative radiotherapy (IORT) for brain metastasis.

Conditions: Brain Metastases
Being tested: intraoperative radiotherapy (IORT)
Medical subject headings: Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intraoperative radiotherapy (IORT)Radiation
intraoperative radiotherapy (IORT) during brain tumor resection to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT)

Study groups in NCT04040400
Study group	Role	What they receive
Treatment Arm	Experimental	intraoperative radiotherapy (IORT) arm Receives: Radiation: intraoperative radiotherapy (IORT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Established Maximum Tolerated Dose
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.
Measured: Phase I cohorts; 90 days from treatments
Number of Participants With Adverse Events
Number of adverse events reported per participant.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201919 Nov 2021

First posted31 Jul 2019
Study start23 Oct 2019
Primary completion19 Nov 2021
Study completion19 Nov 2021

Why it stopped: per DMSC request

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Brain MetastasesStudies of the same condition, open and under way.
More trials run by University of LouisvilleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: The resection procedure should be performed with image guidance (neuronavigation) with standard surgical technique. Optimal balloon applicator size will be selected with accordance to tumor bed/cavity geometry and adjacent normal brain parenchyma by the team of surgeons and radiation oncologists. The radiation oncologist will place the miniature x-ray source inside the balloon shaped catheter placed inside the tumor cavity. Radiotherapy will be initiated by the treating radiation oncologist for a defined time interval calculated by the machine planning software. After IORT has been delivered, the surgeon will remove the balloon applicator. Surgery will be continued in the regular fashion without additional requirements.
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04040400
Sponsor's protocol ID: 19.0619 BCC-IORT-BM
Status last verified: Oct 2023
First submitted: 20 Jul 2019
Last updated: 12 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: No plans to share individual participant data with other researchers outside of this clinical trial's investigation team

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
ClinicalTrials.gov ID: NCT04040400
Acronym / sponsor ID: 19.0619 BCC-IORT-BM
Conditions: Brain Metastases
Study type: Interventional
Recruitment status: TerminatedReason stopped: per DMSC request
Enrolment: 5 participants (actual)
Lead sponsor: University of LouisvilleUniversity, hospital or other
Study start: 23 Oct 2019 (actual)
Primary completion: 19 Nov 2021 (actual)
Study completion: 19 Nov 2021 (actual)
First posted: 31 Jul 2019 (actual)
Results: Posted 12 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: The resection procedure should be performed with image guidance (neuronavigation) with standard surgical technique. Optimal balloon applicator size will be selected with accordance to tumor bed/cavity geometry and adjacent normal brain parenchyma by the team of surgeons and radiation oncologists. The radiation oncologist will place the miniature x-ray source inside the balloon shaped catheter placed inside the tumor cavity. Radiotherapy will be initiated by the treating radiation oncologist for a defined time interval calculated by the machine planning software. After IORT has been delivered, the surgeon will remove the balloon applicator. Surgery will be continued in the regular fashion without additional requirements.

Arm	Type	Receives
Treatment Arm	Experimental	Radiation: intraoperative radiotherapy (IORT)intraoperative radiotherapy (IORT) arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Participants must be ≥ 18 years of age.
Participants must have a Karnosfky performance status of ≥ 50%.
Participants must not have had prior intracranial radiation.
Participants must have a life expectancy greater than 3 months.
Participants must have a preoperative MRI Brain T1-Gadolinum enhanced scan demonstrating a non-dural based lesion with greatest diameter ≥ 2.5 cm.

Key exclusion criteria (7 listed)

Participants may not be pregnant or breast-feeding.
Patients must not have dural lesions or leptomeningeal disease.
Patients must not have psychiatric or social conditions limiting adherence to protocol guidelines.
Patients must not have contraindications to anesthesia, surgery, or MR imaging with Gadolinium injection.
Patients must not have a frozen section diagnosis of small cell carcinoma, lymphoma, germinoma or non-malignant histology.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intraoperative radiotherapy (IORT)intraoperative radiotherapy (IORT) during brain tumor resection to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT)	Radiation	Treatment Arm

Primary outcome

Established Maximum Tolerated Dose
Time frame: 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 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.
Number of Participants With Adverse Events
Time frame: 12 months
Number of adverse events reported per participant.

Results and safety

Results posted to the registry on 12 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm Intraoperative Radiotherapy (IORT)	5	5
Cohort 2	0	0
Cohort 3	0	0

Primary outcome: Established Maximum Tolerated Dose

Time frame: Phase I cohorts; 90 days from treatments. Count of participants. Unit: Participants

Measure	IORT Treatment Arm n = 5
18 Gy	5
21 Gy	0
24 Gy	0

Primary outcome: Number of Participants With Adverse Events

Time frame: 12 months. Number. Unit: participants

Measure	IORT Treatment Arm n = 5
Value	5

Population analysed: participants that received intraoperative radiation.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: 18 Gy	5 of 5 (100%)	1 of 5 (20%)	4 of 5
Cohort 2: 21 Gy	0 of 0	0 of 0	0
Cohort 3: 24 Gy	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plans to share individual participant data with other researchers outside of this clinical trial's investigation team

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shaio Woo, MD principal investigator

University of Louisville, JGBrown Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing intraoperative radiotherapy (IORT) in people with Brain Metastases, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Established Maximum Tolerated Dose (time frame: Phase I cohorts; 90 days from treatments). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040400.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.