Status:
TERMINATED
Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
Lead Sponsor:
University of Louisville
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 br...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 1 Participants receiving cisplatin, methotrexate, taxanes, tyrosine kinase inhibitors, or BRAF targeted agents must have a seven day washout period prior to receiving IORT.
- 2 Participants receiving doxorubicin, T-DM1, or antibody-drug conjugates must have a fourteen day washout period prior to receiving IORT.
- 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
- 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.
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04040400
Start Date
October 23 2019
End Date
November 19 2021
Last Update
October 12 2023
Active Locations (1)
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1
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202