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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
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Head-Neck

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Unique Dataset IDnci-data-412ClinicalTrial.gov IDNCT01302834
DownloadableNo
SponsorNational Cancer InstituteData ProviderNational Cancer InstituteTotal Study Enrolled Patients987RandomizationYesPubMed (PMID)30449625.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, Radiation, BiologicalDataset TypeOther

Clinical Trial Title

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Trial Summary and Conditions

RATIONALE: 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.

Data Summary

See Data Dictionary.

Study Objectives

PRIMARY: To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival. SECONDARY: To monitor and compare progression-free survival for "safety". To compare patterns of failure (locoregional vs distant). To compare acute toxicity profiles (and overall toxicity burden). To compare overall quality of life (QOL) short-term (< 6 months) and long-term (2 years). To compare QOL Swallowing Domains short-term and long-term. To compare clinician-reported versus patient-reported CTCAE toxicity events. To explore differences in the cost effectiveness of cetuximab as compared to cisplatin. To explore differences in work status and time to return to work. To compare patient-reported changes in hearing. To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years. To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival. To pilot CASI collection of patient reported outcomes in a cooperative group setting. To determine whether specific molecular profiles are associated with overall or progression-free survival. To investigate associations between changes in serum biomarkers or human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.

Outcome Measures

PRIMARY OUTCOME MEASURES: 1. Overall Survival. SECONDARY OUTCOME MEASURES: 1. Progression-free Survival. 2. Time to Local-regional Failure. 3. Time to Distant Metastasis. 4. Time to Secondary Primary Cancer. 5. Distribution of First Progression Events. 6. Percentage of Participants Experiencing Early Death. 7. Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During / 1 Month After / 3 Months After / 6 Months After / 1 Year After / 2 Years After / 5 Years After the End of Study Treatment. 8. Percentage of Participants With a Feeding Tube at 1 Year. 9. EORTC QLQ-C30 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment. 10. EORTC QLQ-H&N35 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

This 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.

Available Downloads: NCT01302834-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01302834-D1-Data-Dictionary_2.pdf

DATA: NCT01302834-D1-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT01302834-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01302834-D2-Data-Dictionary_1.pdf

DATA: NCT01302834-D2-Dataset.csv

OTHER: README.pdf