Suspended

Stereotactic Radiosurgery and Fractionated Whole-Brain Radiotherapy for Multiple Primary or Metastatic Brain Tumors

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What is being tested

irradiation

+ radiosurgery

Procedure
Who is being recruted

Brain Diseases+11

+ Central Nervous System Diseases

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1994
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1994

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a randomized study. Tumor size and number are confirmed prior to randomization. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 2 treatment groups. One group is treated with fractionated whole-brain irradiation using megavoltage equipment. The second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. Stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. Either treatment may be administered first; the second treatment begins within 1 month of the first. Concurrent anticonvulsants and steroids are allowed. Patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.

NCT00004659
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsDisease AttributesBrain NeoplasmsGenetic Diseases, InbornRare Diseases

Criteria

Multiple newly diagnosed brain tumors Histologic confirmation of carcinoma at primary or metastatic site Tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm No more than 4 tumors on magnetic resonance imaging Systemic disease controlled Neurologic function preserved Radiographic staging within 2 months of randomization required Performance status: Karnofsky 70%-100%

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers