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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 1999 by Office of Rare Diseases (ORD).
Recruitment status was:  Active, not recruiting
University of Pittsburgh
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999

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.

Condition Intervention Phase
Brain Neoplasms Procedure: irradiation Procedure: radiosurgery Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 40
Study Start Date: November 1994
Detailed 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004659

Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
University of Pittsburgh
Study Chair: Douglas Kondziolka University of Pittsburgh
  More Information Identifier: NCT00004659     History of Changes
Other Study ID Numbers: 199/11858
Study First Received: February 24, 2000
Last Updated: June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):
adult brain tumor
brain tumor
childhood brain tumor
genetic condition
nervous tissue tumors
oncologic disorders
rare disease

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 19, 2017