Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection
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|ClinicalTrials.gov Identifier: NCT04040400|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Device: intraoperative radiotherapy (IORT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||A Phase I/II Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection|
|Actual Study Start Date :||October 23, 2019|
|Estimated Primary Completion Date :||July 15, 2029|
|Estimated Study Completion Date :||July 15, 2034|
Experimental: Treatment Arm
intraoperative radiotherapy (IORT) arm
Device: intraoperative radiotherapy (IORT)
intraoperative radiotherapy (IORT) during brain tumor resection
- 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.
- Final Overall survival [ Time Frame: through study completion, an average of 10 years ]Kaplan-Meier methods and the log-rank test will be used to estimate survival outcomes including overall survival.
- Recurrence rate of treated brain metastasis [ Time Frame: through study completion, an average of 10 years ]Multivariable Cox regression will be used to evaluate prognostic factors associated with survival.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040400
|Contact: Shaio Woo, MDfirstname.lastname@example.org|
|United States, Kentucky|
|University of Louisville, James Graham Brown Cancer Center||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Shaio Woo, MD|
|Principal Investigator:||Shaio Woo, MD||University of Louisville, JGBrown Cancer Center|