Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases
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|ClinicalTrials.gov Identifier: NCT01644591|
Recruitment Status : Recruiting
First Posted : July 19, 2012
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Malignant Neoplasm in the Brain Metastatic Melanoma Pathologic Stage IV Cutaneous Melanoma AJCC v8||Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Radiosurgery||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Determine Local Control and Neurocognitive Preservation After Initial Treatment With Stereotactic Radiosurgery (SRS) for Patients With >3 Melanoma Brain Metastases|
|Actual Study Start Date :||August 2, 2012|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
Experimental: Treatment (SRS)
Patients undergo SRS on day 1.
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Radiation: Stereotactic Radiosurgery
- Time to progression [ Time Frame: Up to 12 months ]Time to local failure will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of local failure rate in patients treated with stereotactic radiosurgery (SRS) to null hypothesis with respect to the time to local failure. Patients who are lost to follow-up or who die from distant disease before having local failure will be censored. Local control rates at 4 months may be estimated with 95% confidence intervals using Kaplan-Meier method.
- Time to neurocognitive failure [ Time Frame: Up to 12 months ]The baseline Listening Vocabulary Levels Test-Revised (HVLT-R) score will be compared to the HVLT-R score in patients surviving 4 months. Preservation of function is defined as improvement of HVLT-R score or decline by 4 points or less. Failure is defined as decline by 5 or more points. Time to neurocognitive decline will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in patients treated with SRS to null hypothesis with respect to the time to neurocognitive decline. Patients who are lost to follow-up or who die before having neurocognitive decline will be censored. Rates of neurocognitive decline at 4 months may be estimated with 95% confidence intervals using Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 12 months ]Will be estimated using the product-limit estimator of Kaplan and Meier. Cox proportional hazards regression will be used to model overall survival as a function of age, Karnofsky performance status, extra-cranial disease, and BRAF mutation status. Will model time to local failure, time to distal failure, and time to neurocognitive decline using competing risk regression when death without events is considered as a competing risk.
- Neurocognitive function score [ Time Frame: Up to 12 months ]Will use descriptive statistics and boxplots to summarize and illustrate the neurocognitive function score at each assessment time. Will similarly summarize and illustrate the change from baseline in neurocognitive function score. Will also fit the neurocognitive data with a general linear model including the baseline score as covariates to assess differences in neurocognitive scores over time (to 4 months) for those patients that are alive and progression-free at 4 months. We will also model the data with mixed effects regression including baseline HVLT-R, time, number of lesions, extra-cranial disease, and a patient specific random effect. Will use logistic regression methods to model the logit of the probability of neurocognitive decline as function of ApoE (i.e., Apo E2, Apo E3, Apo E4) genotyping, inflammatory markers, hormone growth factors.
- Number of cycles of systemic chemotherapy given following radiation treatment [ Time Frame: Up to 12 months ]Will use descriptive statistics to summarize the number of cycles of systemic chemotherapy given following radiation treatment for each treatment arm.
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): NCT01644591
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jing Li 713-563-2300|
|Principal Investigator: Jing Li|
|Principal Investigator:||Erik P Sulman||M.D. Anderson Cancer Center|