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A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases

Phase 3
18 Years
Not Enrolling
Metastatic Cancer

Thank you

Trial Information

A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases


- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with
radiosurgery with or without whole brain radiotherapy.

- Compare the time to CNS failure (brain) in patients treated with these regimens.

- Compare the quality of life, duration of functional independence, and long-term
neurocognitive status in patients treated with these regimens.

- Compare the post-treatment toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(60 and over vs under 60), extracranial disease (controlled for more than 3 months vs
controlled for 3 months or less), and number of brain metastases (1 vs more than 1).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiosurgery.

- Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole
brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3
months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.

Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1
year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this
study within 5 years.

Inclusion Criteria


- Diagnosis of cerebral metastases meeting all of the following requirements:

- 1-3 de novo lesions

- Metastases must be from a histologically confirmed extracerebral primary site,
another metastatic site, or from the metastatic brain lesion(s)

- Each lesion must be less than 3.0 cm by contrasted MRI of the brain

- Lesions must not be within 5 mm of optic chiasm or within the brainstem

- No primary germ cell tumor, small cell carcinoma, or lymphoma

- No leptomeningeal metastases

- Eligible for treatment with gamma knife or linear accelerator-based radiosurgery



- 18 and over

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Male patients must continue to use contraception for 3 months after the
completion of radiotherapy

- No pacemaker or other MRI-incompatible metal in body

- No known allergy to gadolinium

- Deemed to be at low risk for recurrence from any prior malignancies


Biologic therapy:

- Not specified


- At least 7 days since prior chemotherapy

Endocrine therapy:

- Concurrent hormonal agents allowed

- Concurrent steroids allowed


- See Disease Characteristics

- No prior cranial radiotherapy


- No prior resection of cerebral metastasis


- Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained
before study intervention

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Anthony Asher, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Carolina Neurosurgery and Spine Associates


United States: Federal Government

Study ID:




Start Date:

December 2001

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
John F. Kennedy Medical Center Edison, New Jersey  08818
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Sutter Cancer Center Sacramento, California  95816
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Foundation for Cancer Research and Education Phoenix, Arizona  85013
UCSF Comprehensive Cancer Center San Francisco, California  94115
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
American Fork Hospital American Fork, Utah  84003
Josephine Ford Cancer Center at Henry Ford Health System Detroit, Michigan  48202
Shands Cancer Center at the University of Florida Health Science Center Gainesville, Florida  32610-0296
University of Illinois Medical Center Chicago, Illinois  60612
Brigham and Women's Hospital Boston, Massachusetts  02115
Mount Diablo Regional Cancer Center Concord, California  94524-4110
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
UPMC St. Margaret Pittsburgh, Pennsylvania  15215
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
Carolina Neurosurgery and Spine Associates Charlotte, North Carolina  28207-1830
John Muir Comprehensive Cancer Center at John Muir Medical Center Walnut Creek, California  94598
University of Pittsburgh Medical Center - Shadyside Hospital Pittsburgh, Pennsylvania  15213-2582
Methodist Cancer Center at Methodist University Hospital Memphis, Tennessee  38104