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Type(s) of Cancer
Esophageal
Study Phase
Phase 3
Study Completion Date
2015-04
NCT00655876Uploaded 09-02-2020
Access via NCI by Request
PDS UID: nci-data-423
A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison in trial NCT00655876.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.
ConditionsEsophageal Cancer
Intervention TypeDrug: cetuximab
Drug: cisplatin
Drug: paclitaxel
Radiation: radiation therapy
Drug(s)Drug: cetuximab
Drug: cisplatin
Drug: paclitaxel
Total Enrolled344
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionChemoradiation + Cetuximab - Experimental
Chemoradiation - Active Comparator
Secondary IDCDR0000538085
PubMed (PMID)28687830
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
Region(s)United States
Canada
Age Range18 Years to 74 Years (ADULT, OLDER_ADULT)
Files: NCT00655876-D1
Data DictionaryNCT00655876-D1-Data-Dictionary_1.pdf
DATANCT00655876-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00655876-D2
Data DictionaryNCT00655876-D2-Data-Dictionary_1.pdf
DATANCT00655876-D2-Dataset.csv
OTHERREADME.pdf
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