Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	ACOSOG-Z0300 NCT00030628

Objectives

1. Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
2. Compare the time to CNS failure (brain) in patients treated with these regimens.
3. Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
4. Compare the post-treatment toxic effects of these regimens in these patients.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Anthony Asher, MD, FACS, Protocol chair		Ph: 704-376-1605; 800-344-6716 Email: tony.asher@cnsa.com

Registry Information
Official Title		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
Trial Start Date		2001-12-06
Registered in ClinicalTrials.gov		NCT00030628
Date Submitted to PDQ		2001-12-13
Information Last Verified		2004-09-21
NCI Grant/Contract Number		CA76001

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