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Phase 2
N/A
N/A
Open (Enrolling)
Both
Brain Neoplasms

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Trial Information


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.

Inclusion 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%

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Douglas Kondziolka

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

199/11858

NCT ID:

NCT00004659

Start Date:

November 1994

Completion Date:

Related Keywords:

  • Brain Neoplasms
  • adult brain tumor
  • brain tumor
  • childhood brain tumor
  • genetic condition
  • nervous tissue tumors
  • oncologic disorders
  • rare disease
  • Brain Neoplasms
  • Neoplasms

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