Access Data

Back to the List

Type(s) of Cancer
Head-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

Partial set or SubsetN/A

Patients in dataset987

# of Patients Control0

# of Patients ExperimentalNA

DOIN/A

CDISC StandardNCI standard

Study ArmsUndefined

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 RangeMinimum Age: 18 Years
Maximum Age: 120 Years

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