Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
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|ClinicalTrials.gov Identifier: NCT01705548|
Recruitment Status : Suspended
First Posted : October 12, 2012
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Malignant Neoplasm to Brain Unspecified Adult Solid Tumor, Protocol Specific||Radiation: Hypofractionated Radiosurgery||Not Applicable|
To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week.
OUTLINE: This is a dose-escalation study.
Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks.
After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2021|
Experimental: Hypofractionated Radiosurgery
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Radiation: Hypofractionated Radiosurgery
Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
- Maximum tolerated dose (MTD) of hypofractionated radiosurgery defined as the highest dose level where a grade 3 or greater with an attribution score of ≥ 3 develops in ≤ 2 of 6 patients in a dose group [ Time Frame: 4 months ]Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
- Neurologic toxicity due to treatment, graded according to the CTCAE version 4.03 [ Time Frame: Up to 2 years ]Calculated with 95% CI.
- Local control; lack of progression of disease in resection cavity as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: 4 months ]The median time to local brain progression will be calculated by Kaplan-Meier method with 95% CI.
- Distant control: lack of progression of disease in surrounding brain as defined by RECIST criteria [ Time Frame: 4 months ]The median time to distant brain progression will be calculated by Kaplan-Meier method with 95% CI.
- Freedom from failure/progression free survival [ Time Frame: Up to 2 years ]
- Overall survival (OS): death from any cause [ Time Frame: Up to 2 years ]The median of OS time with 95% CI will be calculated by Kaplan-Meier method.
- Long-term neurocognitive outcomes: using the Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam (MMSE) and Cognitive Functioning Subscale of the Medical Outcomes Scale (MOS) [ Time Frame: Up to 2 years ]Neurocognitive effect will be regressed over time using generalized estimating equation (GEE) model. The population change over time (slope) will be estimated with 95% CI.
- Quality of life (QOL) outcomes: using the quality of life questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br). [ Time Frame: Up to 2 years ]QOL outcomes will be regressed over time using GEE model. The population change over time (slope) will be estimated with 95% CI.
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): NCT01705548
|United States, Georgia|
|Emory University Hospital/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Bree Eaton, MD||Emory University|