Phase II Randomized Study of Stereotactic Radiosurgery Plus Fractionated Whole-Brain Radiotherapy Vs Fractionated Whole-Brain Radiotherapy Alone for Multiple Primary or Metastatic Brain Tumors

NCT00004659 | Unknown Phase 2

• 2 other identifiers: 199/11858UPPUH-9511117
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple sites in patients with primary or metastatic brain tumors, controlled systemic disease, and preserved neurologic function. II. Examine survival, clinical outcome, and local tumor imaging response in these patients.

Conditions

Brain Neoplasms

Keywords

adult brain tumor; brain tumor; childhood brain tumor; genetic condition; nervous tissue tumors; oncologic disorders; rare disease

Interventions

irradiation PROCEDURE

radiosurgery PROCEDURE

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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%

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• University of Pittsburgh: collaborator

MeSH Terms

Conditions

Brain Neoplasms; Genetic Diseases, Inborn; Rare Diseases

Interventions

Radiation; Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Douglas Kondziolka

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: November 1, 1994
• Last Updated: June 24, 2005

Record last verified: 1999-03