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Type(s) of Cancer
Head and Neck
Study Phase
Phase 3
Study Completion Date
July 2018
NCT01302834Uploaded 04-28-2020
Access via NCI by Request
PDS UID: nci-data-412
Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between arm 1 and arm 2 in trial NCT01302834. Specifically, this dataset contains baseline, treatment, survival, pre-specified treatment related adverse event, swallowing domain, and dental gingival health data.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
ConditionsHead and Neck Cancer
Precancerous Condition
Intervention TypeBiological: cetuximab
Drug: cisplatin
Radiation: IMRT
Drug(s)Drug: cisplatin
Total Enrolled987
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionIMRT + Cisplatin - Active Comparator
IMRT + Cetuximab - Active Comparator
Secondary IDCDR0000695731
PubMed (PMID)30449625
25057165
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
Region(s)United States
Canada
Age Range18 Years to 120 Years (Adult, Older Adult)
Files: NCT01302834-D1
Data DictionaryNCT01302834-D1-Data-Dictionary_2.pdf
DATANCT01302834-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01302834-D2
Data DictionaryNCT01302834-D2-Data-Dictionary_1.pdf
DATANCT01302834-D2-Dataset.csv
OTHERREADME.pdf
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