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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00377156

First received: September 13, 2006

Last updated: July 25, 2017

Last verified: July 2017

History of Changes

Results First Received: February 27, 2017

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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Arm I (SRS)	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.
Arm II (SRS+WBRT)	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.

Description

Arm I (SRS)

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.

Arm II (SRS+WBRT)

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.

Participant Flow: Overall Study

	Arm I (SRS)	Arm II (SRS+WBRT)
STARTED	111	102
COMPLETED	63	48
NOT COMPLETED	48	54
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

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Arm I (SRS)	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.
Arm II (SRS+WBRT)	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	Total of all reporting groups

Description

Arm I (SRS)

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.

Arm II (SRS+WBRT)

> 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

Total of all reporting groups

Baseline Measures

	Arm I (SRS)	Arm II (SRS+WBRT)	Total
Overall Participants Analyzed [Units: Participants]	111	102	213

Age [Units: Years] Mean (Standard Deviation)	59.8 (10.4)	61.4 (10.6)	60.6 (10.5)

Age, Customized [Units: Participants] Count of Participants
18 to 59	53	44	97
>= 60	58	58	116

Sex: Female, Male [Units: Participants] Count of Participants
Female	57 51.4%	47 46.1%	104 48.8%
Male	54 48.6%	55 53.9%	109 51.2%

Region of Enrollment [Units: Participants]
Canada	23	22	45
United States	88	80	168

Outcome Measures

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1. Primary:

Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months [ Time Frame: 3 months post radiosurgery ]

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2. Secondary:

Number of Participants With Local and Distant Tumor Control up to 3 Months [ Time Frame: Up to 3 months ]

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3. Secondary:

Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month] [ Time Frame: From Baseline to 3-Month Evaluation ]

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4. Secondary:

Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months [ Time Frame: From baseline to 12 months ]

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5. Secondary:

Overall Survival [ Time Frame: Up to 5 years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Paul Brown, M.D.
Organization: Mayo Clinic
phone: 507-538-0948
e-mail: Brown.Paul@mayo.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Ménard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-9. doi: 10.1001/jama.2016.9839.

Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT00377156 History of Changes
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) )
Study First Received:	September 13, 2006
Results First Received:	February 27, 2017
Last Updated:	July 25, 2017

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