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Type(s) of Cancer
CNS
Study Phase
Phase 2Phase 3
Study Completion Date
2005-08
NCT00003375Uploaded 07-06-2024
Access via NCI by Request
PDS UID: nci-data-547
A Phase II Study of Observation in Favorable Low-Grade Glioma and a Phase II Study of Radiation With or Without PCV Chemotherapy in Unfavorable Low-Grade Glioma
Provider Information
Provider Data DescriptionThis dataset, NCT00003375-D1, contains the outcome and select genomic data from the NRG/RTOG-98-02 secondary publication PMID 32706640, which provides a comprehensive genomic analysis of the trial. There are two other datasets containing data from PMID 32706640.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy combined with chemotherapy is more effective than radiation therapy alone in treating patients with low-grade glioma. PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma.
ConditionsBrain and Central Nervous System Tumors
Intervention TypeDrug: lomustine
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
Drug(s)Drug: lomustine
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Total Enrolled370
RandomizationRandomized
Blinding MethodNone
Arms InterventionObservation - No Intervention
Radiation therapy - Experimental
Radiation plus PCV chemotherapy - Experimental
Secondary IDCDR0000066367
PubMed (PMID)24419119
22851558
18976072
32706640
27050206
Collaborator(s)National Cancer Institute (NCI)
SWOG Cancer Research Network
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NRG Oncology
Region(s)N/A
Age Range18 Years to 120 Years (ADULT, OLDER_ADULT)
Files: NCT00003375-D1
Data DictionaryNCT00003375-D1-Data-Dictionary.pdf
DATANCT00003375-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00003375-D2
Data DictionaryNCT00003375-D2-Data-Dictionary.pdf
DATANCT00003375-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00003375-D3
Data DictionaryNCT00003375-D3-Data-Dictionary.pdf
DATANCT00003375-D3-Dataset.csv
OTHERREADME.pdf
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