A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed With Stereotactic Radiosurgery (SRS)

NCT01821443 | Terminated DMC

• 1 other identifier: 12105/12-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, stereotactic radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of giving radiation therapy to the brain in a very focused way, so that nearby parts of the brain receive very little exposure to radiation. No incisions are involved. Imaging technology is used to pinpoint the location of the tumor. In this study, the investigators are also trying to find out how the tumor and/or treatment affect brain function over time. The investigators will do this by performing a series of neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before treatment and at regular intervals after treatment.

Conditions

Brain Metastases

Keywords

1 to 10 measurable brain metastases

Outcome Measures

Primary Outcomes (2)

• Gamma knife radiosurgery treatment

  Two short oNCF assessments will be performed at least 30 minutes prior to a clinical neurocognitive function (cNCF) assessments directed by a neuropsychologist at baseline and 6 months following Gamma knife treatment to assess changes in the participants' ability to complete all assessments.

  Baseline and 6-months following treatment

• Validation: To estimate consistency in change in z-scores for online oNCF and comprehensive clinical neurocognitive function (cNCF) neurocognitive assessments at baseline and 6-months in the office/clinic setting.

  * Neuro psychologist will perform assessments: global cognitive function (Montreal Cognitive Assessment (MoCA), fine motor skills (Grooved Pegboard), information processing speed (DKEFS Trails, Symbol-Digit Modality Test), auditory and visual attention (NAB Digit Span, Numbers and Letters A), verbal memory (NAB List Learning and Story Learning), visual memory (NAB Shape Learning and Rey-Osterrieth Complex Figure (ROCF), Brief Visuospatial Memory Test-Revised (BVMT-R™), language (Boston Naming Test, Letter Fluency, Category Fluency, Sentence Repetition), visual-spatial (NAB Visual Discrimination, ROCF) and DKEFS Trails, DKEFS Design Fluency). * Patient will complete Quality of Life Questionnaire- Core 30 (QOL-30), Brain Cancer Module-20 (BCM20), and EuroQol Group Questionnaire-5D (EQ-5D) QoL measurements. * Patient will complete self-reported measures of depression (BDI-II), anxiety (BAI), qualify of life (FACT-Br), cognition (FACT-COG), and fatigue (Fatigue Severity Scale).

  baseline and 6-months following radiosurgery

Secondary Outcomes (2)

• -Feasibility: To demonstrate that at least 95% of participants will have no change from baseline and 12 months after treatment in their ability to complete the online neurocognitive function (oNCF) assessment.

  baseline and 12-months after therapy.

• - Validation: To estimate consistency and change in scores for online neurocognitive (oNCF) and comprehensive clinical neurocognitive function (cNCF) assessments over all study time points.

  baseline and 12-months after treatment.

Other Outcomes (2)

• To determine what healthcare cost data can be collected in patients with metastatic disease with the aim of estimating the relative healthcare cost of the Gamma Knife radiosurgery (prospective cost data collection).

  Participants will be followed for the duration of hospital stay and initial follow up, an expected average of 6 weeks

• Document the incidence of asymptomatic and symptomatic radiation necrosis in patients treated with gamma knife radiosurgery with or without whole brain radiation therapy WBRT (if WBRT is offered as salvage therapy)

  12 months post radiosugery

Study Arms (1)

Stereotactic Radiosurgery (SRS)

EXPERIMENTAL

Stereotactic radiosurgery technique via Gamma Knife® Perfexion™ radiosurgical system

Other: Stereotactic radiosurgery (SRS)

Interventions

Stereotactic radiosurgery (SRS) OTHER

Dose \& prescription The dose will be prescribed to the isodose surface, which encompasses the margin of the metastasis (50-90% \[maximum=100%\]), as defined by target delineation on the imaging studies. The prescribed dose is dependent on the prescription isodose volume (IDV). The prescription IDV is defined as the volume (cm3) that is encompassed by the prescription isodose line (IDL).

Also known as: Gamma Knife® Perfexion™ radiosurgical system

Stereotactic Radiosurgery (SRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological confirmation is required (e.g. from extra- or intracranial disease).
• Patients with 1-10 measurable brain metastases on a diagnostic-quality contrast-enhanced magnetic resonance imaging (MRI) scan obtained within 30 days prior to registration.
• Patients with ≤10 cc largest tumor volume, and ≤15 cc total tumor volume.
• History/physical examination within 30 days prior to registration.
• If an open biopsy is performed, the patient must be at least one week post biopsy. This requirement does not apply to patients who undergo stereotactic biopsies.
• Age ≥18 years.
• Karnofsky performance status ≥70 (RTOG recursive partitioning analysis (RPA) Class I \& II).
• Minimum pre-treatment oNCF score ≥70.
• Patients must provide study-specific informed consent prior to study entry.
• Women of child-bearing age must have a negative, quantitative serum pregnancy test ≤14 days prior to study entry, or have a documented reason why such a test is not necessary (e.g. history of tubal ligation).
• Patients must be able to speak and read English fluently (required for the use of online NCF testing).

You may not qualify if:

• Clinical (e.g. multiple cranial nerve deficits in the absence of obvious radiographic disease to explain symptoms) or radiographic evidence of leptomeningeal disease.
• Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
• No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received. Note: This does not apply to patients with synchronous metastases at initial diagnosis.
• Contraindication to MR imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration.
• Estimated glomerular filtration rate (eGFR) \<60 within 6 weeks prior to registration.
• Prior radiation therapy to the brain.
• Severe, active co-morbidity, defined as follows:
• Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
• Transmural myocardial infarction within the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization, or precluding study therapy at the time of registration.
• Uncontrolled, clinically significant cardiac arrhythmias.
• Radiologic or clinical evidence of hydrocephalus, or history of previously treated hydrocephalus.

Sponsors & Collaborators

• University of California, San Francisco: lead
• North American Gamma Knife Consortium: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Igor J Barani, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: April 1, 2013
• Study Start: December 1, 2012
• Primary Completion: October 22, 2015
• Study Completion: October 22, 2015
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)