NCT01890278|Unknown
Phase II Trial of Conventional Versus IMRT Whole Brain Radiotherapy for Brain Metastases
Randomized Phase II Trial of Conventional vs IMRT Whole Brain Radiotherapy for Brain Metastases
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Randomized Phase II Trial of Conventional vs IMRT Whole Brain Radiotherapy for Brain Metastases
Sponsor study identifier
interventional
60
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In this study the patient will receive either whole brain radiation therapy given by intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT therapy radiation dose to the parts of the brain that do not contain tumors is reduced. This study will look to see if this approach results in less hair loss or fewer memory Problems, as compared to the standard technique. The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 13, 2013
Actual (reported)July 1, 2013
Actual (reported)March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Alopecia
In this study the patient will receive either whole brain radiation therapy given by intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT therapy radiation dose to the parts of the brain that do not contain tumors is reduced.
1 to 4 months after radiation
The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.
1 year
Quality of life
1 year after radiation
Whole brain radiation therapy delivered via IMRT (37.5 Gy to brain tumor, 30 Gy to the uninvolved brain in 15 fractions), mean dose of less than 18 Gy to scalp.
Conventional whole brain radiation therapy (37.5 Gy to the brain tumors and uninvolved brain in 15 fractions).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Good Samaritan Hospital Medical Center
West Islip, New York, 11795, United States
Horton J, Baxter DH, Olson KB. The management of metastases to the brain by irradiation and corticosteroids. Am J Roentgenol Radium Ther Nucl Med. 1971 Feb;111(2):334-6. doi: 10.2214/ajr.111.2.334. No abstract available.
Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.
Johnny Kao, MD
Good Samaritan Hospital Medical Center
First Submitted
June 13, 2013
First Posted
July 1, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2017
Estimated (date passed)Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor
Contact the study team to confirm eligibility.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 1, 2013
Record last verified: 2013-06
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