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Type(s) of Cancer
CNS
Study Phase
Phase 3
Study Completion Date
October 2014
NCT00377156Uploaded 09-13-2022
Access via NCI by Request
PDS UID: nci-data-493
Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases
Provider Information
Provider Data DescriptionThe NCT00377156-D1 (BASE) dataset is one of 5 datasets associated with PubMed ID 27458945. This dataset provides information on patient evaluability, baseline demographics, stratification factors, baseline QOL measures, baseline cognitive scores, and intracranial (brain) tumor progression and survival status and time. There is one observation per patient accrued to this study (N=213). Due to data cleaning efforts subsequent to publication, data may contain slight discrepancies from that reported in Table 1 and Figure1.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
ConditionsBreast Cancer
Cognitive/Functional Effects
Lung Cancer
Metastatic Cancer
Prostate Cancer
Intervention TypeRadiation: radiation therapy
Radiation: stereotactic radiosurgery
Drug(s)N/A
Total Enrolled213
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Secondary IDNCCTG-N0574
PubMed (PMID)28939223
27458945
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00377156-D1
Data DictionaryNCT00377156-D1-Data-Dictionary_2.pdf
DATANCT00377156-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00377156-D2
Data DictionaryNCT00377156-D2-Data-Dictionary_2.pdf
DATANCT00377156-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00377156-D3
Data DictionaryNCT00377156-D3-Data-Dictionary_2.pdf
DATANCT00377156-D3-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00377156-D4
Data DictionaryNCT00377156-D4-Data-Dictionary_2.pdf
DATANCT00377156-D4-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00377156-D5
Data DictionaryNCT00377156-D5-Data-Dictionary_2.pdf
DATANCT00377156-D5-Dataset_2.csv
OTHERREADME.pdf
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