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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:

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Head-Neck

A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

Unique Dataset IDnci-data-381ClinicalTrial.gov IDNCT00265941
DownloadableNo
SponsorRadiation Therapy Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients940RandomizationYesPubMed (PMID)25154822.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, RadiationDataset TypeOther

Clinical Trial Title

A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

Trial Summary and Conditions

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Cisplatin may also make tumor cells more sensitive to radiation therapy. 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. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary: Evaluate whether the addition of cetuximab to a concurrent radiation-cisplatin regimen will improve progression-free survival in patients with stage III or IV squamous cell carcinoma of the oropharynx, hypopharynx, or larynx. Secondary: Determine the impact of the addition of cetuximab to a concurrent radiation-cisplatin regimen on overall survival, local-regional control, acute and late toxic effects, quality of life, and health utilities in these patients. Correlate the expression of epidermal growth factor receptor (EGFR) and its down-stream molecules with outcome in patients participating in this component of the trial. Correlate pre-treatment positron emission tomography (PET) scan findings with progression-free survival, overall survival, and local-regional control in patients participating in this component of the trial. Correlate post-treatment PET scan findings with nodal response and nodal relapse in patients participating in this component of the trial. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to primary site (larynx vs non-larynx), nodal stage (N0 vs N1, N2a, N2b vs N2c, N3), Zubrod performance status (0 vs 1), use of intensity modulated radiotherapy (IMRT) (no vs yes), and pre-treatment PET/CT scan (no vs yes). Patients are randomized to 1 of 2 treatment arms. NOTE: *A neck dissection is optional for patients with multiple lymph nodes or lymph nodes > 3 cm in diameter who achieve a complete clinical and radiographic response in the neck. Quality of life is assessed at baseline, once during the last 2 weeks of treatment, at 3 and 12 months from the start of treatment, and then annually for 4 years. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

Outcome Measures

Primary: Progression-free Survival (PFS) (3-year Rate Reported) Secondary: Overall Survival (OS) (3-year Rate Reported) Local-regional Failure (LRF) (3-year Rate Reported) Rate of Mucositis Toxicity >= Grade 3 Rate of Other Toxicity >= Grade 3 (Not Mucositis) Rate of Patients Who Tolerated Treatment Rate of Deaths <= 30 Days After Discontinuation of Protocol Treatment Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D)Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores <= 50 Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF 2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response

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 adverse event tables in trial NCT00265941.

Available Downloads: NCT00265941-D2

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

Data Dictionary: NCT00265941-D2-Data-Dictionary.pdf

DATA: NCT00265941-D2-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265941-D1

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

Data Dictionary: NCT00265941-D1-Data-Dictionary_1.pdf

DATA: NCT00265941-D1-Dataset.csv

OTHER: README.pdf