Neurocognitive Outcomes In Patients Treated With Radiotherapy For Five Or More Brain Metastases (NAGKC 12-01)
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|ClinicalTrials.gov Identifier: NCT01731704|
Recruitment Status : Withdrawn (Insufficient staff)
First Posted : November 22, 2012
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: Stereotactic radiosurgery (SRS) Radiation: Whole brain radiation therapy (WBRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Study Of Neurocognitive Outcomes In Patients With Five Or More Brain Metastases Treated With Radiosurgery Or Whole-Brain Radiotherapy|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 26, 2015|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Stereotactic Radiosurgery (SRS)
Radiation Therapy: Radiosurgical (SRS) technique via Gamma Knife Perfexion radiosurgical system
Radiation: Stereotactic radiosurgery (SRS)
Other Name: Gamma knife Perfexion radiosurgical device
Active Comparator: Whole Brain Radiation Therapy (WBRT)
whole-brain radiation therapy 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks
Radiation: Whole brain radiation therapy (WBRT)
External beam whole-brain radiation therapy 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks
- To compare the relative change in neurocognitive outcomes (change in oNCF z-score) between baseline and 6 months for surviving patients in upfront WBRT vs. SRS treatment groups. [ Time Frame: Every 3 months for 12 months ]
All participants will be asked to complete:
- Online brain function testing: Complete a short 20-minute online brain function (cognitive) assessment every 2 weeks (twice per month, at least 10-14 days apart).
- Quality of Life Questionnaire: Complete a self-reported (if patient) and caregiver quality of life questionnaires every 10-12 weeks (2.5-3 months). These questionnaires take approximately 15-20 minutes to complete and can be done online or in clinic during follow-up visits.
- To compare the relative change in neurocognitive outcomes (change in oNCF z-score) between baseline and 12 months for surviving patients in upfront WBRT vs. SRS treatment groups. [ Time Frame: Every 10-12 weeks for 12 months after treatment ]
- Neurocognitive function, 12-months post whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS)specifically the Gamma Knife (GK) system, treatment as measured by the online neurocognitive function (oNCF) composite z-score.
- Neurocognitive function at all time points as measured by the online neurocognitive function (oNCF) composite z-score.
- To compare the relative impact of initial therapy on patients' quality of life (QoL) as measured by caregiver assessments [ Time Frame: Every 10-12 weeks for 12 months after treatment ]• Quality of life (patient-reported measures) as measured by Beck Depression Inventory, Beck Anxiety Inventory, FACT-Br, FACT-Cog, Fatigue Severity Scale, EuroQol(EQ5D), EORTC-BN20, and QOL-30.
- To compare the relative impact of initial therapy on patients' quality of life (QoL) as measured by caregiver assessments [ Time Frame: Every 10-12 months ]Quality of life as measured by caregiver assessments including Frontal Systems Behavior Scale, Neuropsychiatric Inventory, Functional Activities Questionnaire, and Everyday Cognition Questionnaire.
- To estimate consistency and change in z-scores for oNCF assessments over all study endpoints in surviving patients treated with upfront whole brain radiation therapy (WBRT) vs. stereotactic radiosurgery (SRS). [ Time Frame: Every 10-12 months ]
- To compare proportions of patients in the two treatment groups that require salvage therapy as a function of systemic disease control (controlled vs. uncontrolled). [ Time Frame: 3, 6, 9, and 12 months ]
- To compare the overall survival between patients in upfront whole brain radiation therapy (WBRT) vs. stereotactic radiosurgery (SRS) treatment groups [ Time Frame: baseline to study completion ]
- Cost analysis [ Time Frame: Prior to treatment up to 12 months after treatment is complete ]To determine what healthcare cost data can be collected in patients with metastatic disease within a context of a multi-institutional clinical trial.
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): NCT01731704
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Study Chair:||Igor J Barani, MD||University of California, San Francisco|