Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases
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|ClinicalTrials.gov Identifier: NCT01843413|
Recruitment Status : Recruiting
First Posted : April 30, 2013
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tumors Metastatic to Brain Unspecified Adult Solid Tumor||Radiation: stereotactic radiosurgery Procedure: quality-of-life assessment Procedure: cognitive assessment||Not Applicable|
I. To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improved with increasing doses of SRS. (Phase II)
I. To determine the risk of acute and long-term toxicity with increasing dose of SRS. (Phase II) II. To determine if there is increased neurocognitive toxicity with increased dose of SRS.
III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI).
After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Dose escalation for radiotherapy|
|Masking:||None (Open Label)|
|Official Title:||Dose Escalation for Larger Brain Metastases: Phase I/II Study|
|Actual Study Start Date :||July 2, 2013|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Treatment (SRS)
Patients undergo SRS guided by CT and MRI.
Radiation: stereotactic radiosurgery
Procedure: quality-of-life assessment
Other Name: quality of life assessment
Procedure: cognitive assessment
- Maximum-tolerated dose based on the incidence of dose-limiting toxicity (DLT) defined as any grade III or IV toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: Up to 4 months ]
- Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II) [ Time Frame: Up to 2 years ]
- Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II) [ Time Frame: Up to 2 years ]Toxicity will be summarized as frequencies and percentages with a corresponding exact 95% confidence interval.
- Quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-BR) and the European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire Core 30 (QLQ30) [ Time Frame: Up to 12 months ]
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): NCT01843413
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Samuel T. Chao 216-445-7876 firstname.lastname@example.org|
|Principal Investigator: Samuel T. Chao|
|Principal Investigator:||Samuel Chao, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|