Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00377156 |
Recruitment Status :
Completed
First Posted : September 15, 2006
Results First Posted : August 24, 2017
Last Update Posted : February 12, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Breast Cancer Cognitive/Functional Effects Lung Cancer Metastatic Cancer Prostate Cancer |
Interventions |
Radiation: radiation therapy Radiation: stereotactic radiosurgery |
Enrollment | 213 |
Recruitment Details | At 34 institutions in North America, patients with 1 to 3 brain metastases were randomized to receive SRS or SRS plus WBRT between February 2002 and December 2013. 70 patients accrued by ACOSOG Z0300 were included in the power calculation and also included for this study. |
Pre-assignment Details |
Arm/Group Title | Arm I (SRS) | Arm II (SRS+WBRT) |
---|---|---|
![]() |
Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter. |
Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.> > Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS. |
Period Title: Overall Study | ||
Started | 111 | 102 |
Completed | 63 | 48 |
Not Completed | 48 | 54 |
Reason Not Completed | ||
Death | 23 | 19 |
Withdrawal by Subject | 16 | 24 |
Had follow-up <90 d | 3 | 6 |
Cancellation | 1 | 0 |
Refused testing | 0 | 1 |
Ineligible | 0 | 1 |
Disability or language problem | 0 | 1 |
Other | 5 | 2 |
Arm/Group Title | Arm I (SRS) | Arm II (SRS+WBRT) | Total | |
---|---|---|---|---|
![]() |
Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter. |
Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.> > Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 111 | 102 | 213 | |
![]() |
[Not Specified]
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 111 participants | 102 participants | 213 participants | |
59.8 (10.4) | 61.4 (10.6) | 60.6 (10.5) | ||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 111 participants | 102 participants | 213 participants |
18 to 59 |
53 47.7%
|
44 43.1%
|
97 45.5%
|
|
>= 60 |
58 52.3%
|
58 56.9%
|
116 54.5%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 111 participants | 102 participants | 213 participants | |
Female |
57 51.4%
|
47 46.1%
|
104 48.8%
|
|
Male |
54 48.6%
|
55 53.9%
|
109 51.2%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 111 participants | 102 participants | 213 participants |
Canada | 23 | 22 | 45 | |
United States | 88 | 80 | 168 |
Name/Title: | Paul Brown, M.D. |
Organization: | Mayo Clinic |
Phone: | 507-538-0948 |
EMail: | Brown.Paul@mayo.edu |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00377156 |
Other Study ID Numbers: |
N0574 NCCTG-N0574 ACOSOG-N0574 CDR0000499633 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-2009-00653 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) |
First Submitted: | September 13, 2006 |
First Posted: | September 15, 2006 |
Results First Submitted: | February 27, 2017 |
Results First Posted: | August 24, 2017 |
Last Update Posted: | February 12, 2020 |