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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



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