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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
Sponsor:
Information provided by (Responsible Party):
Johnny Kao, Good Samaritan Hospital Medical Center, New York

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Brain Cancer Radiation: Whole Brain IMRT Radiation: Conventional Whole Brain RT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

ELIGIBILITY CHECKLIST

Inclusion Criteria:

  • Evidence of at least one brain metastasis on a gadolinium contrast-enhanced MRI
  • Pathologic/histological/cytologic proof of a diagnosis of a non-hematopoietic malignancy within 5 years of study entry.
  • Patient ≥18 years of age?
  • Fall into RTOG Recursive Partition Analysis (RPA) class I or II.
  • Karnofsky Performance Score ≥70. (See Appendix III)
  • Biopsy done at least 1 week prior to registration. (This requirement does not apply to stereotactic biopsies.)

Exclusion Criteria:

  • Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia.
  • Creatinine level > 1.4 mg/dl drawn ≤30 days prior to study entry.
  • Severe, active co-morbitities.
  • Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Uncontrolled, clinically significant cardiac arrhythmias
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890278


Contacts
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Contact: Johnny Kao, MD 631-376-4047 johnny.kao@chsli.org
Contact: Linda M Reuter 631-376-3093 linda.reuter@chsli.org

Locations
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United States, New York
Good Samaritan Hospital Medical Center Recruiting
West Islip, New York, United States, 11795
Contact: Johnny Kao, MD    631-376-4047    johnny.kao@chsli.org   
Principal Investigator: Johnny Kao, MD         
Sponsors and Collaborators
Good Samaritan Hospital Medical Center, New York
Investigators
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Principal Investigator: Johnny Kao, MD Good Samaritan Hospital Medical Center

Publications:

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Responsible Party: Johnny Kao, Principal Investigator, Good Samaritan Hospital Medical Center, New York
ClinicalTrials.gov Identifier: NCT01890278     History of Changes
Other Study ID Numbers: 12-005
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: June 2013

Keywords provided by Johnny Kao, Good Samaritan Hospital Medical Center, New York:
Brain Cancer
Metastatic Brain Cancer
IMRT

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases