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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
N/A
Not Enrolling
Both
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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 7 days since prior chemotherapy

Endocrine therapy:

- Concurrent hormonal agents allowed

- Concurrent steroids allowed

Radiotherapy:

- See Disease Characteristics

- No prior cranial radiotherapy

Surgery:

- No prior resection of cerebral metastasis

Other:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Anthony Asher, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Carolina Neurosurgery and Spine Associates

Authority:

United States: Federal Government

Study ID:

CDR0000069183

NCT ID:

NCT00030628

Start Date:

December 2001

Completion Date:

Related Keywords:

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

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
John F. Kennedy Medical CenterEdison, New Jersey  08818
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sutter Cancer CenterSacramento, California  95816
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
American Fork HospitalAmerican Fork, Utah  84003
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
University of Illinois Medical CenterChicago, Illinois  60612
Brigham and Women's HospitalBoston, Massachusetts  02115
Mount Diablo Regional Cancer CenterConcord, California  94524-4110
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
UPMC St. MargaretPittsburgh, Pennsylvania  15215
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Carolina Neurosurgery and Spine AssociatesCharlotte, North Carolina  28207-1830
John Muir Comprehensive Cancer Center at John Muir Medical CenterWalnut Creek, California  94598
University of Pittsburgh Medical Center - Shadyside HospitalPittsburgh, Pennsylvania  15213-2582
Methodist Cancer Center at Methodist University HospitalMemphis, Tennessee  38104