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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00548756 |
Primary Objectives:
Condition | Intervention | Phase |
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Brain Cancer |
Procedure: Whole Brain Radiation Therapy Other: Observation Behavioral: Questionnaire |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Prospective Randomized Trial Comparing Radiosurgery With Versus Without Whole Brain Radiotherapy for 1-3 Newly Diagnosed Brain Metastases |
Estimated Enrollment: | 152 |
Study Start Date: | January 2001 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Whole Brain Radiation Therapy
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Procedure: Whole Brain Radiation Therapy
Whole Brain Radiation Therapy. Total dose = 30 Gy over 12 fractions at 2.5Gy per fraction.
Behavioral: Questionnaire
Questionnaire taking 40 minutes to complete.
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2
Observation
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Other: Observation
Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions.
Behavioral: Questionnaire
Questionnaire taking 40 minutes to complete.
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TREATMENT:
Before treatment starts, patients will have a complete history (including details of previous chemotherapy, radiotherapy, and surgery for systemic disease). Patients will have a complete neuropsychological exam and will have their Karnofsky Performance Score (KPS) figured out. Seven cognitive function tests and a quality of life (QOL) questionnaire will be given to the patients as well. It will take about 40 minutes to complete the QOL questionnaire.
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. Patients in one group will receive immediate whole brain radiation therapy. Patients in the other group will hold off on radiation and just be closely observed. There is an equal chance of being in either group.
All patients will receive radiosurgery treatment to the known metastases (1-3 lesions) at the beginning. All participants will be followed with serial diagnostic and functional MRI. Experimental functional imaging will be used to evaluate short-term memory and picture recognition as well as blood flow within the brain.
Formal neuropsychological testing will also be performed at each follow-up interval. Patients will be seen for follow-up with neuropsychological evaluation, as well as diagnostic/function MRI at 1 , 2 , 4 , 6 , 9 , 12 , 15 , and 18 months and then every six months from then on. Each visit will require about 40 minutes of time.
Cost information related to protocol treatment and subsequent therapies will be tracked and collected for cost analysis between the two treatment groups.
Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions. If there are greater than 2 lesions, whole brain radiation will be given. If there are 1-2 lesions, patients will be randomly assigned to a local treatment (surgery or radiosurgery) or whole brain radiation therapy. Further recurrences in patients having not yet received whole brain radiation will be given this treatment at the time of recurrence.
The expected length of the study is 3.8 years with 6 months follow-up following the end of the study. Thus, the length of participation can range from 6 months for patients enrolling at the end of the study to over 4 years for patients enrolling at the beginning.
This is an investigational study. A total of 152 patients will take part in the study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Post-entry exclusion: No post-entry exclusions will be allowed after registration has occurred. All randomized patients will be included in the analysis and those lost to follow-up will be assigned the least favorable outcome (recurrence, death).
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Eric L. Chang, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Eric L. Chang, MD/Associate Professor ) |
Study ID Numbers: | ID00-377 |
Study First Received: | October 22, 2007 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00548756 History of Changes |
Health Authority: | United States: Institutional Review Board |
Brain Cancer Whole Brain Radiation Therapy Quality of Life QOL |
Questionnaire Survey WBRT |
Brain Neoplasms Neoplasm Metastasis Quality of Life Central Nervous System Diseases |
Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Brain Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |