Patients receive gallium Ga 68-DOTATATE IV and undergo a PET/MRI before cycles 1 and 4. Patients then receive lutetium Lu 177 dotatate IV over 30-40 minutes. Cycles repeat every 8 for up to 6 months in the absence of disease progression or unacceptable toxicity.

Grade I Meningioma

Grade II Meningioma

Grade III Meningioma

Recurrent Meningioma

Unresectable Meningioma

Gallium Ga 68-DOTATATE

Lutetium Lu 177 Dotatate

Magnetic Resonance Imaging

Positron Emission Tomography

Quality-of-Life Assessment

Questionnaire Administration

Mayo Clinic

Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

A Prospective, Phase II Study of Lutetium Lu 177 Dotatate (LUTATHERA?) in Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy

Will be defined as the number of evaluable patients not having progressive disease or death within six months of the first day of treatment divided by the total number of evaluable patients. The proportion of successes in each cohort will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper-Pearson. There will be no formal comparison of rates among the two different grade cohorts of patients.

The distribution of survival time for both cohorts will be estimated using the method of Kaplan-Meier. No formal comparison will be made among the cohorts.

The distribution of time to progression will be estimated using the method of Kaplan-Meier (Kaplan et. al 1958). No formal comparison will be made among the cohorts.

Will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

QOL will be measured using the standard survey series for this population of patients, and QOL trajectory over time will be examined. The survey series includes Promise-10. The QOL impact will be measured with differences from baseline to 6, 12 and 24 months in patient reported outcomes via the symptom scales (measurement of day to day level of function and health determined by the patient) from four combined surveys. Scale ranges from excellent to poor. No formal comparisons will be made among the cohorts.

QOL will be measured using the standard survey series for this population of patients, and QOL trajectory over time will be examined. The survey series includes a Brief Fatigue Inventory questionnaire. QOL analyses will be exploratory and may include change from baseline to all time points using t-test and generalized linear models to test for changes at each time point and non-zero slopes, respectfully. Response to questionnaire range from no fatigue to as bad as you can imagine. No formal comparisons will be made among the cohorts.

QOL will be measured using the standard survey series for this population of patients, and QOL trajectory over time will be examined. The survey series includes the European Quality of Life Five Dimension Five Level questionnaire. Mobility, Self-care, Activity level, Pain/discomfort, and Anxiety/Depression will be measured by the patient. All other QOL analyses will be exploratory and may include change from baseline to all time points using t-test and generalized linear models to test for changes at each time point and non-zero slopes, respectfully. No formal comparisons will be made among the cohorts.

QOL will be measured using the standard survey series for this population of patients, and QOL trajectory over time will be examined. The survey series includes the Mayo Patient Survey National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Brain Symptom Index Questionnaire-24 (version 2) questionnaire. Response to questionnaire range from Not at all to Very much. All other QOL analyses will be exploratory and may include change from baseline to all time points using t-test and generalized linear models to test for changes at each time point and non-zero slopes, respectfully. No formal comparisons will be made among the cohorts.

Will be defined as a best objective response of stable disease, partial or complete response to treatment as determined by Macdonald Criteria. The proportion of patients who have achieved local control will be summarized by cohort and 95% confidence intervals calculated according to the methods described in Clopper-Pearson. No formal comparison will be made among the cohorts.

The distribution of local control and survival without progression as a competing risk model will be constructed using Kaplan-Meier estimates. No formal comparisons will be made amongst the cohorts.

Will be determined by Macdonald Criteria. The proportion of patients in each response category will be summarized by cohort and 95% confidence intervals calculated according to the methods described in Clopper-Pearson. No formal comparison will be made among the cohorts.

The response rate determined by volumetric analysis will be estimated for each cohort with proportion of patients who achieve complete response/partial response deemed by volumetric analysis. The 90% two-sided confidence intervals will be calculated according to approach of Clopper-Pearson. No formal comparison will be made among the cohorts.

National Cancer Institute (NCI)

Patients follow the evidence-based cognitive rehabilitation program ReMind, which is provided via an iPad. It incorporates psychoeducation, strategy training and retraining. The intervention commenced 3 months after surgery and patients were advised to spend 3 hours per week on the program for 10 weeks.

The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery.

Brain Tumor, Primary

Cognitive Impairment

Cognitive rehabilitation, i.e. psychoeducation, strategy training & retraining

The cognitive rehabilitation program ReMind

Erasmus Medical Center

Medical Center Haaglanden

Elisabeth-TweeSteden Hospital

Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery

Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs

Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III)

Word fluency is measured with the Letter Fluency test

Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ)

Fatigue is measured with the Multidimensional Fatigue Inventory (MFI)

Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS)

Depression is measured with the Hospital Anxiety and Depression Scale (HADS)

Subjective executive functioning is measured with the Behavior Rating Inventory of Executive Function

Professional functioning is measured with the Work Ability Index (WAI)

Professional functioning is measured with the Work Limitation Questionnaire (WLQ)

Participation is measured with the Community Integration Questionnaire (CIQ)

Elisabeth-TweeSteden Ziekenhuis

University of Tilburg

ZonMw: The Netherlands Organisation for Health Research and Development

Well-trained research assistants, who are conducting neuropsychological assessments, are blinded.

meningioma/vermoeidheid

Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery

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