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Type(s) of Cancer
CNS
Study Phase
Phase 3
Study Completion Date
2016-08
NCT01372774Uploaded 09-14-2022
Access via NCI by Request
PDS UID: nci-data-494
A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared With Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease
Provider Information
Provider Data DescriptionDataset NCT01372774-D1-Dataset.csv (baseline) is one of 5 datasets associated with PubMed ID 28687377. This dataset contains information that will allow you to reproduce the baseline characteristics table and time to event analyses.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Stereotactic radiosurgery may be able to 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 radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery. PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
ConditionsCognitive/Functional Effects
Metastatic Cancer
Neurotoxicity
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeRadiation: stereotactic radiosurgery
Radiation: whole-brain radiation therapy
Drug(s)N/A
Total Enrolled194
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I - WBRT - Active Comparator
Arm II - SRS - Experimental
Secondary IDNCCTG-N107C
PubMed (PMID)36264568
28687377
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01372774-D1
Data DictionaryNCT01372774-D1-Data-Dictionary_1.pdf
DATANCT01372774-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01372774-D2
Data DictionaryNCT01372774-D2-Data-Dictionary_1.pdf
DATANCT01372774-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01372774-D3
Data DictionaryNCT01372774-D3-Data-Dictionary_1.pdf
DATANCT01372774-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01372774-D4
Data DictionaryNCT01372774-D4-Data-Dictionary_1.pdf
DATANCT01372774-D4-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01372774-D5
Data DictionaryNCT01372774-D5-Data-Dictionary_1.pdf
DATANCT01372774-D5-Dataset_1.csv
OTHERREADME.pdf
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