- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040400
Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
A Phase I/II Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville, James Graham Brown Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
intraoperative radiotherapy (IORT) arm
|
intraoperative radiotherapy (IORT) during brain tumor resection to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Phase I cohorts; 90 days from treatments
|
Number of Participants With Adverse Events
Time Frame: 12 months
|
Number of adverse events reported per participant.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Time Frame: through study completion, an average of 10 years
|
The Questionnaire Functional Assessment of Cancer Therapy (FACT) is a self-reported quality of life questionnaire that includes 27 items. The brain tumor specific version, is an additional 23-item sub-scale set of disease-specific questions pertaining to brain neoplasms. Patients rate each question using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Item areas are: physical well-being, social/family well-being, emotional well-being, functional well-being and sub-scale item area relevant to patients with brain tumors. Overall, higher ratings suggest higher Quality of Life score. Items are totaled (summed) to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items). |
through study completion, an average of 10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shaio Woo, MD, University of Louisville, JGBrown Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19.0619 BCC-IORT-BM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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