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

Brain Neoplasms Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00004659
• Other study ID #: 199/11858
• Secondary ID: UPPUH-9511117
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: November 1994

Study information

• Verified date: March 1999
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• 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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Procedure:
• irradiation

• radiosurgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)	University of Pittsburgh