ClinicalTrials.gov

History of Changes for Study: NCT00377156
Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Latest version (submitted February 4, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2006 None (earliest Version on record)
2 September 26, 2006 Study Status
3 September 29, 2006 Study Status
4 October 12, 2006 Study Status and Study Description
5 November 8, 2006 Study Status, Study Design, Outcome Measures, Conditions and Study Identification
6 November 16, 2006 Recruitment Status, Study Status and Contacts/Locations
7 December 6, 2006 Contacts/Locations and Study Status
8 January 5, 2007 Conditions and Study Status
9 January 11, 2007 Conditions and Study Status
10 January 16, 2007 Study Status and Contacts/Locations
11 January 30, 2007 Study Status, Contacts/Locations and Eligibility
12 February 8, 2007 Contacts/Locations and Study Status
13 March 20, 2007 Contacts/Locations and Study Status
14 April 9, 2007 Contacts/Locations and Study Status
15 April 11, 2007 Study Status and Contacts/Locations
16 May 16, 2007 Study Status and Contacts/Locations
17 June 4, 2007 Contacts/Locations and Study Status
18 June 6, 2007 Contacts/Locations and Study Status
19 June 20, 2007 Contacts/Locations and Study Status
20 July 10, 2007 Contacts/Locations and Study Status
21 July 17, 2007 Study Status and Contacts/Locations
22 August 6, 2007 Contacts/Locations and Study Status
23 August 14, 2007 Contacts/Locations and Study Status
24 August 24, 2007 Contacts/Locations and Study Status
25 August 28, 2007 Contacts/Locations and Study Status
26 September 10, 2007 Study Status and Contacts/Locations
27 September 18, 2007 Contacts/Locations and Study Status
28 October 13, 2007 Study Status and Contacts/Locations
29 October 19, 2007 Contacts/Locations and Study Status
30 October 25, 2007 Arms and Interventions and Study Status
31 November 2, 2007 Contacts/Locations and Study Status
32 November 6, 2007 Study Status and Contacts/Locations
33 November 9, 2007 Contacts/Locations and Study Status
34 November 14, 2007 Contacts/Locations and Study Status
35 November 17, 2007 Contacts/Locations and Study Status
36 November 21, 2007 Contacts/Locations and Study Status
37 December 6, 2007 Contacts/Locations, Conditions and Study Status
38 December 8, 2007 Conditions and Study Status
39 December 11, 2007 Study Status and Contacts/Locations
40 December 15, 2007 Contacts/Locations and Study Status
41 December 25, 2007 Study Status
42 January 11, 2008 Contacts/Locations and Study Status
43 January 17, 2008 Recruitment Status, Study Status and Contacts/Locations
44 January 18, 2008 Recruitment Status, Study Status and Contacts/Locations
45 January 22, 2008 Contacts/Locations and Study Status
46 January 26, 2008 Contacts/Locations and Study Status
47 January 30, 2008 Contacts/Locations and Study Status
48 January 31, 2008 Contacts/Locations and Study Status
49 February 7, 2008 Study Status and Contacts/Locations
50 February 19, 2008 Contacts/Locations and Study Status
51 February 27, 2008 Contacts/Locations and Study Status
52 March 5, 2008 Study Status and Contacts/Locations
53 April 8, 2008 Study Status and Contacts/Locations
54 April 10, 2008 Contacts/Locations and Study Status
55 April 12, 2008 Contacts/Locations and Study Status
56 April 17, 2008 Contacts/Locations and Study Status
57 April 19, 2008 Contacts/Locations and Study Status
58 April 22, 2008 Contacts/Locations and Study Status
59 April 23, 2008 Contacts/Locations and Study Status
60 April 30, 2008 Contacts/Locations and Study Status
61 May 6, 2008 Study Status and Contacts/Locations
62 May 13, 2008 Study Status
63 May 22, 2008 Contacts/Locations and Study Status
64 May 24, 2008 Arms and Interventions and Study Status
65 May 30, 2008 Contacts/Locations and Study Status
66 June 11, 2008 Contacts/Locations and Study Status
67 June 13, 2008 Study Status and Contacts/Locations
68 June 18, 2008 Arms and Interventions and Study Status
69 June 24, 2008 Contacts/Locations and Study Status
70 July 2, 2008 Study Status and Contacts/Locations
71 July 10, 2008 Contacts/Locations and Study Status
72 July 23, 2008 Study Design and Study Status
73 July 31, 2008 Contacts/Locations and Study Status
74 August 2, 2008 Contacts/Locations and Study Status
75 August 27, 2008 Arms and Interventions and Study Status
76 September 2, 2008 Study Status and Contacts/Locations
77 September 5, 2008 Contacts/Locations and Study Status
78 September 17, 2008 Contacts/Locations and Study Status
79 September 22, 2008 Contacts/Locations and Study Status
80 October 8, 2008 Study Status and Contacts/Locations
81 October 9, 2008 Contacts/Locations, Sponsor/Collaborators and Study Status
82 October 10, 2008 Contacts/Locations and Study Status
83 October 16, 2008 Contacts/Locations and Study Status
84 October 18, 2008 Conditions and Study Status
85 October 21, 2008 Contacts/Locations and Study Status
86 October 22, 2008 Study Status
87 November 1, 2008 Contacts/Locations and Study Status
88 November 4, 2008 Contacts/Locations and Study Status
89 November 7, 2008 Contacts/Locations and Study Status
90 November 18, 2008 Contacts/Locations and Study Status
91 November 19, 2008 Contacts/Locations and Study Status
92 December 16, 2008 Study Status
93 December 19, 2008 Contacts/Locations and Study Status
94 December 24, 2008 Contacts/Locations and Study Status
95 January 2, 2009 Study Status and Contacts/Locations
96 January 6, 2009 Contacts/Locations and Study Status
97 January 10, 2009 Contacts/Locations and Study Status
98 January 15, 2009 Contacts/Locations and Study Status
99 January 16, 2009 Contacts/Locations and Study Status
100 January 21, 2009 Contacts/Locations and Study Status
101 January 22, 2009 Contacts/Locations and Study Status
102 January 23, 2009 Contacts/Locations and Study Status
103 January 27, 2009 Contacts/Locations and Study Status
104 January 31, 2009 Contacts/Locations and Study Status
105 February 3, 2009 Study Status and Contacts/Locations
106 February 5, 2009 Arms and Interventions, Contacts/Locations and Study Status
107 February 7, 2009 Contacts/Locations and Study Status
108 February 10, 2009 Contacts/Locations and Study Status
109 February 12, 2009 Contacts/Locations and Study Status
110 February 14, 2009 Contacts/Locations and Study Status
111 February 25, 2009 Contacts/Locations and Study Status
112 March 7, 2009 Study Status and Contacts/Locations
113 March 13, 2009 Contacts/Locations and Study Status
114 March 18, 2009 Contacts/Locations and Study Status
115 April 8, 2009 Study Status and Contacts/Locations
116 April 11, 2009 Contacts/Locations and Study Status
117 April 14, 2009 Contacts/Locations, Sponsor/Collaborators and Study Status
118 April 18, 2009 Contacts/Locations and Study Status
119 April 30, 2009 Contacts/Locations and Study Status
120 May 7, 2009 Study Status and Contacts/Locations
121 May 9, 2009 Conditions and Study Status
122 June 2, 2009 Contacts/Locations and Study Status
123 June 9, 2009 Study Status and Contacts/Locations
124 June 17, 2009 Contacts/Locations and Study Status
125 June 19, 2009 Contacts/Locations and Study Status
126 July 16, 2009 Study Status and Contacts/Locations
127 July 21, 2009 Contacts/Locations and Study Status
128 August 5, 2009 Study Status and Contacts/Locations
129 August 22, 2009 Contacts/Locations and Study Status
130 August 25, 2009 Conditions and Study Status
131 August 27, 2009 Contacts/Locations and Study Status
132 September 2, 2009 Contacts/Locations and Study Status
133 September 10, 2009 Contacts/Locations and Study Status
134 September 16, 2009 Contacts/Locations and Study Status
135 September 22, 2009 Contacts/Locations and Study Status
136 October 6, 2009 Study Status and Contacts/Locations
137 October 7, 2009 Contacts/Locations and Study Status
138 October 13, 2009 Contacts/Locations and Study Status
139 October 14, 2009 Contacts/Locations and Study Status
140 November 17, 2009 Contacts/Locations and Study Status
141 November 26, 2009 Contacts/Locations and Study Status
142 December 2, 2009 Study Status and Contacts/Locations
143 December 3, 2009 Contacts/Locations and Study Status
144 December 15, 2009 Contacts/Locations and Study Status
145 December 30, 2009 Contacts/Locations and Study Status
146 January 8, 2010 Study Status and Contacts/Locations
147 January 16, 2010 Contacts/Locations and Study Status
148 January 21, 2010 Contacts/Locations and Study Status
149 January 23, 2010 Contacts/Locations and Study Status
150 January 26, 2010 Eligibility and Study Status
151 February 1, 2010 Contacts/Locations and Study Status
152 February 10, 2010 Study Status and Contacts/Locations
153 February 17, 2010 Contacts/Locations and Study Status
154 February 26, 2010 Contacts/Locations and Study Status
155 February 27, 2010 Contacts/Locations and Study Status
156 March 6, 2010 Study Status
157 March 9, 2010 Contacts/Locations and Study Status
158 March 18, 2010 Contacts/Locations and Study Status
159 March 19, 2010 Contacts/Locations and Study Status
160 April 1, 2010 Contacts/Locations and Study Status
161 April 10, 2010 Study Status and Contacts/Locations
162 April 16, 2010 Contacts/Locations and Study Status
163 May 5, 2010 Study Status and Contacts/Locations
164 May 12, 2010 Contacts/Locations and Study Status
165 May 18, 2010 Contacts/Locations and Study Status
166 May 21, 2010 Contacts/Locations and Study Status
167 May 25, 2010 Contacts/Locations and Study Status
168 June 5, 2010 Study Status and Contacts/Locations
169 June 15, 2010 Contacts/Locations and Study Status
170 June 24, 2010 Contacts/Locations and Study Status
171 August 3, 2010 Study Status and Contacts/Locations
172 August 7, 2010 Study Status and Contacts/Locations
173 August 14, 2010 Contacts/Locations and Study Status
174 August 17, 2010 Contacts/Locations and Study Status
175 August 18, 2010 Contacts/Locations and Study Status
176 August 21, 2010 Contacts/Locations and Study Status
177 September 2, 2010 Study Status and Contacts/Locations
178 September 16, 2010 Study Status
179 September 25, 2010 Contacts/Locations and Study Status
180 October 7, 2010 Contacts/Locations and Study Status
181 October 9, 2010 Contacts/Locations and Study Status
182 October 19, 2010 Contacts/Locations and Study Status
183 October 26, 2010 Contacts/Locations and Study Status
184 October 27, 2010 Contacts/Locations and Study Status
185 November 3, 2010 Study Status and Contacts/Locations
186 November 23, 2010 Contacts/Locations and Study Status
187 November 24, 2010 Contacts/Locations and Study Status
188 December 8, 2010 Study Status and Contacts/Locations
189 December 16, 2010 Contacts/Locations and Study Status
190 December 21, 2010 Contacts/Locations and Study Status
191 January 5, 2011 Study Status and Contacts/Locations
192 January 7, 2011 Contacts/Locations and Study Status
193 January 11, 2011 Contacts/Locations and Study Status
194 January 13, 2011 Contacts/Locations and Study Status
195 February 2, 2011 Contacts/Locations and Study Status
196 February 3, 2011 Contacts/Locations and Study Status
197 February 5, 2011 Contacts/Locations and Study Status
198 February 11, 2011 Contacts/Locations and Study Status
199 March 1, 2011 Contacts/Locations, Conditions and Study Status
200 March 11, 2011 Study Status and Contacts/Locations
201 March 12, 2011 Contacts/Locations and Study Status
202 March 16, 2011 Study Design, Study Description and Study Status
203 March 19, 2011 Contacts/Locations and Study Status
204 March 31, 2011 Contacts/Locations and Study Status
205 April 7, 2011 Study Status, Contacts/Locations and Conditions
206 May 3, 2011 Contacts/Locations and Study Status
207 May 7, 2011 Study Status and Contacts/Locations
208 June 16, 2011 Contacts/Locations and Study Status
209 July 16, 2011 Study Status and Contacts/Locations
210 July 27, 2011 Contacts/Locations and Study Status
211 June 17, 2012 Contacts/Locations and Study Status
212 June 19, 2012 Contacts/Locations and Study Status
213 June 28, 2012 Contacts/Locations and Study Status
214 June 29, 2012 Contacts/Locations and Study Status
215 July 4, 2012 Study Status and Contacts/Locations
216 July 13, 2012 Contacts/Locations and Study Status
217 July 19, 2012 Contacts/Locations and Study Status
218 July 24, 2012 Contacts/Locations and Study Status
219 August 3, 2012 Study Status and Contacts/Locations
220 August 7, 2012 Contacts/Locations and Study Status
221 August 10, 2012 Contacts/Locations and Study Status
222 August 12, 2012 Contacts/Locations and Study Status
223 September 18, 2012 Study Status and Contacts/Locations
224 October 10, 2012 Study Status and Contacts/Locations
225 October 11, 2012 Contacts/Locations and Study Status
226 October 24, 2012 Contacts/Locations and Study Status
227 November 1, 2012 Contacts/Locations and Study Status
228 November 13, 2012 Study Status and Contacts/Locations
229 December 13, 2012 Study Status and Contacts/Locations
230 December 21, 2012 Contacts/Locations and Study Status
231 January 12, 2013 Study Status and Contacts/Locations
232 January 20, 2013 Contacts/Locations and Study Status
233 February 7, 2013 Study Status and Contacts/Locations
234 February 8, 2013 Contacts/Locations and Study Status
235 February 12, 2013 Contacts/Locations and Study Status
236 February 26, 2013 Contacts/Locations and Study Status
237 July 26, 2013 Outcome Measures, Study Identification, Contacts/Locations, Sponsor/Collaborators, Study Status, Study Design and Oversight
238 August 19, 2013 Study Status
239 June 10, 2015 Recruitment Status, Study Status and Contacts/Locations
240 September 18, 2015 Sponsor/Collaborators, Study Status and Contacts/Locations
241 November 23, 2015 Study Status and Arms and Interventions
242 August 11, 2016 Study Status
243 July 25, 2017 Study Status, Outcome Measures, Study Design, Results and Contacts/Locations
244 January 22, 2019 Study Status
245 February 4, 2020 Recruitment Status, Study Status and Outcome Measures
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Study NCT00377156
Submitted Date:  September 13, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000499633
Brief Title: Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Official Title: Phase III Randomized Study of Stereotactic Radiosurgery With Versus Without Whole-Brain Radiotherapy in Patients With Cerebral Metastases
Secondary IDs: NCCTG-N0574
ACOSOG-N0574
Open or close this module Study Status
Record Verification: September 2006
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: September 13, 2006
First Submitted that
Met QC Criteria:
September 13, 2006
First Posted: September 15, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 13, 2006
Last Update Posted: September 15, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: North Central Cancer Treatment Group
Responsible Party:
Collaborators: National Cancer Institute (NCI)
American College of Surgeons
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.

PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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) over 30-90 minutes.
  • Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy over 10-20 minutes 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.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 528 patients will be accrued for this protocol.

Open or close this module Conditions
Conditions: Breast Cancer
Cognitive and Functional Effects
Lung Cancer
Male Breast Cancer
Metastatic Cancer
Prostate Cancer
Keywords: cognitive/functional effects
adult 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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Procedure: cognitive assessment
Procedure: quality-of-life assessment
Procedure: radiation therapy
Procedure: stereotactic radiosurgery
Procedure: supportive care/therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

DISEASE CHARACTERISTICS:

  • 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
  • No clinical or radiographic evidence of systemic progression (other than the study lesion[s]) within the past month
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Open or close this module Contacts/Locations
Study Officials: Paul D. Brown, MD
Study Chair
Mayo Clinic
Kurt A. Jaeckle, MD
Mayo Clinic
Richard L. Deming, MD
Therapeutic Radiology Associates, P. C.
Elana Farace, PhD
Milton S. Hershey Medical Center
Bruce Pollock, MD
Mayo Clinic
Anthony Asher, MD, FACS
Study Chair
Carolina Neurosurgery and Spine Associates
Fred G. Barker, MD
Massachusetts General Hospital
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services