Neurocognitive Outcomes In Patients Treated With Radiotherapy For Five Or More Brain Metastases

Study summary

This is randomized study of neurocognitive outcomes in patients with five or more brain metastases treated with stereotactic radiosurgery (SRS), specifically the Gamma Knife (GK) system, or whole-brain radiation therapy (WBRT). The primary aim of this study is to compare the change in neurocognitive function outcome between baseline and 6 months in WBRT versus SRS treatment groups.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic radiosurgery (SRS) and Whole brain radiation therapy (WBRT)

The study team can explain what participation involves.

Who it may be forBrain Metastases

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 14, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of California, San Francisco

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: University of California, San Francisco
Interventions being studied: Radiation: Stereotactic radiosurgery (SRS); Radiation: Whole brain radiation therapy (WBRT)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Radiation therapy→Surgery→

Study topics

Brain metastases→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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 intra-cranial disease).
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.
Patients with ≥5 measurable brain metastases on a diagnostic-quality contrast-enhanced magnetic resonance imaging (MRI) 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.
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).
Patients must demonstrate basic computer literacy skills and have access to an internet terminal (required for the use of online NCF testing).

Reasons someone may not be able to joinExclusion criteria

Clinical (e.g. multiple new 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.
Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study is potentially teratogenic

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California, San FranciscoSan Francisco, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 14, 2017. Always confirm current availability with the study team.

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