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Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases

Phase 3
18 Years
Open (Enrolling)
Breast Cancer, Cognitive/Functional Effects, Lung Cancer, Metastatic Cancer, Prostate Cancer

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Trial Information

Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases



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


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

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

- Compare post-treatment toxicity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for
> 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo stereotactic radiosurgery (SRS).

- Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo
whole-brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life, functional independence, and neurocognitive status are assessed at
baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16,
24 , 36, 48, and 60 months.

PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol.

Inclusion Criteria


- Diagnosis of cerebral metastases meeting the following criteria:

- One to three presumed brain metastases

- Metastases must be from a histologically confirmed extracerebral site (e.g.,
lung, breast, prostate)

- Histologic confirmation may have been from the primary tumor site, from
another metastatic site (e.g., osseous metastasis, adrenal metastasis), or
from the metastatic brain lesion(s)

- Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed
within the past 21 days

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

- Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery
confirmed by a radiation oncologist

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

- No leptomeningeal metastases

- Hormone receptor status not specified


- Male or female

- Menopausal status not specified

- ECOG performance status 0-2

- 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 the body

- No known allergy to gadolinium


- More than 7 days since prior and no concurrent chemotherapy

- No prior cranial radiotherapy

- No prior resection of cerebral metastases

- Concurrent hormonal agents, steroids, and/or anticonvulsants allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months

Safety Issue:


Principal Investigator

Paul D. Brown, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic



Study ID:




Start Date:

July 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cognitive/Functional Effects
  • Lung Cancer
  • Metastatic Cancer
  • Prostate Cancer
  • cognitive/functional effects
  • tumors metastatic to brain
  • stage IV breast cancer
  • stage IV prostate cancer
  • stage IV non-small cell lung cancer
  • male breast cancer
  • recurrent breast cancer
  • recurrent prostate cancer
  • recurrent non-small cell lung cancer
  • Breast Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms



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St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
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Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara, California  95051-5386
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
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Kaiser Permanente Medical Center - Santa Rosa Santa Rosa, California  95403
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Immanuel Medical Center Omaha, Nebraska  68122
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
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St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
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Lowell General Hospital Lowell, Massachusetts  01854
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Kaiser Permanente - Division of Research - Oakland Oakland, California  94611
Rohnert Park Cancer Center Rohnert Park, California  94928
Coastal Carolina Radiation Oncology Center Wilmington, North Carolina  28401
Seacoast Cancer Center at Wentworth - Douglass Hospital Dover, New Hampshire  03820
Saint Vincent Hospital at Worcester Medical Center Worcester, Massachusetts  01608