Phase II Trial of Conventional Versus IMRT Whole Brain Radiotherapy for Brain Metastases
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|ClinicalTrials.gov Identifier: NCT01890278|
Recruitment Status : Unknown
Verified June 2013 by Johnny Kao, Good Samaritan Hospital Medical Center, New York.
Recruitment status was: Recruiting
First Posted : July 1, 2013
Last Update Posted : July 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Brain Cancer||Radiation: Whole Brain IMRT Radiation: Conventional Whole Brain RT||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of Conventional vs IMRT Whole Brain Radiotherapy for Brain Metastases|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
Active Comparator: Whole Brain IMRT
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.
Radiation: Whole Brain IMRT
Active Comparator: Conventional whole brain RT
Conventional whole brain radiation therapy (37.5 Gy to the brain tumors and uninvolved brain in 15 fractions).
Radiation: Conventional Whole Brain RT
- Alopecia [ Time Frame: 1 to 4 months after radiation ]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.
- The study will also look at the effectiveness of both techniques in controlling the growth of the tumor. [ Time Frame: 1 year ]IMRT is more expensive than conventional treatment therefor it is important to evaluation whether the newer technique improves quality of life.
- Quality of life [ Time Frame: 1 year after radiation ]Quality of life as assessed by Mini-mental status examination and patient reported EORTC-BN20 instrument
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890278
|Contact: Johnny Kao, MDemail@example.com|
|Contact: Linda M Reuterfirstname.lastname@example.org|
|United States, New York|
|Good Samaritan Hospital Medical Center||Recruiting|
|West Islip, New York, United States, 11795|
|Contact: Johnny Kao, MD 631-376-4047 email@example.com|
|Principal Investigator: Johnny Kao, MD|
|Principal Investigator:||Johnny Kao, MD||Good Samaritan Hospital Medical Center|