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

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	RTOG-9508 NCT00002708, RTOG-95-08

Objectives

I. Compare the overall survival of patients with one unresected brain 
metastasis treated with conventional whole brain radiotherapy (WBRT) with vs. 
without a stereotactic radiosurgery (SRS) boost.

II.  Compare sites of recurrence and cause of death in these patients treated 
with WBRT followed by SRS vs. WBRT alone.

Entry Criteria

Disease Characteristics:

No more than 1 unresected or subtotally resected brain metastasis lesion from
histologically confirmed systemic malignancy
  
Eligible only if surgical resection refused by patient or resection deemed
inappropriate by patient's physician

1 intraparenchymal metastasis clearly defined on contrast enhanced MRI
  
Maximum diameter of lesion no greater than 4.0 cm
   
No leukemia or lymphoma

Extracranial sites of primary metastatic disease allowed if no clinical or
radiographic evidence of progression within 1 month prior to entry

No metastasis to brainstem, midbrain, pons, or medulla

No leptomeningeal metastasis by MRI or CSF evaluation

No metastasis within 10 mm of optic nerves and chiasm (area must be excluded
from high dose stereotactic radiosurgery boost field)

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No concurrent chemotherapy for systemic cancer

Endocrine therapy:
 Concurrent hormonal therapy, including tamoxifen, allowed 

Radiotherapy:
 No prior cranial radiotherapy

Surgery:
 Prior subtotal resection allowed

Other:
 No other concurrent treatment for brain metastasis until recurrence
 

Patient Characteristics:

Age:
 18 and over

Performance status:
 70-100% Karnofsky

Hematopoietic:
 Absolute neutrophil count at least 1,000/mm3
 Platelet count at least 50,000/mm3
 Hemoglobin at least 8 g/dL

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 Neurologic status 0-2
 No major medical or psychiatric contraindication to protocol entry
 Fertile patients must use effective contraception 

Expected Enrollment

A total of 262 patients will be accrued over 2.5-3.75 years for this study.  
The study may close early if interim analysis after 33% and 67% of patients 
have been followed for 6 months produces significant results.  After 6/14/99 
an additional 46 patients with a solitary brain metastasis only will be 
accrued.  

Outline

This is a randomized, multicenter study.  Patients are stratified according to 
center and extracranial disease (yes or no).  Patients are randomized to one 
of two treatment arms. 

Arm I:  Patients receive fractionated external beam whole brain irradiation 
(WBRT) 5 days each week for 3 weeks.  Both portals are treated during each 
radiotherapy session.  Patients who still have a solitary lesion with a 
diameter no greater than 4.0 cm also receive stereotactic radiosurgery within 
7 days of completing WBRT.

Arm II:  Patients receive WBRT only.

Patients are followed every 3 months for 1 year, then every 4 months for 2 
years, and then annually.

Hazard LJ, Jensen RL, Shrieve DC: Role of stereotactic radiosurgery in the treatment of brain metastases. Am J Clin Oncol 28 (4): 403-10, 2005.[PUBMED Abstract]

Andrews DW, Scott CB, Sperduto PW, et al.: Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet 363 (9422): 1665-72, 2004.[PUBMED Abstract]

Sperduto PW, Scott C, Andrews D: Stereotactic radiosurgery with whole brain radiation therapy improves survival in patients with brain metastases: report of Radiation Therapy Oncology Group phase III study 95–08. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): 3, 2002.

Sperduto P, Scott C, Andrews D, et al.: Preliminary report of RTOG 95-08: a phase III trial comparing whole brain irradiation alone versus whole brain irradiation plus stereotactic radiosurgery for patients with two or three unresected brain metastases. [Abstract] Int J Radiat Oncol Biol Phys 48: A-6, 113, 2000.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

David Andrews, MD, FACS, Protocol chair		Ph: 215-503-7005; 800-533-3669 Email: david.andrews@jefferson.edu

Registry Information
Official Title		A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES
Trial Start Date		1996-01-31
Trial Completion Date		2004-12-17
Registered in ClinicalTrials.gov		NCT00002708
Date Submitted to PDQ		1996-01-31
Information Last Verified		2008-03-04
NCI Grant/Contract Number		CA21661