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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
June 2013
NCT00533949Uploaded 01-30-2018
Access via NCI by Request
PDS UID: nci-data-361
A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce adverse event tables in trial NCT00533949.
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin 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 high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
ConditionsLung Cancer
Radiation Toxicity
Intervention TypeBiological: Cetuximab
Drug: Carboplatin
Drug: Paclitaxel
Radiation: 60 Gy RT
Radiation: 74 Gy RT
Drug(s)Drug: Carboplatin
Drug: Paclitaxel
Total Enrolled544
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms Intervention60 Gy RT - Active Comparator
74 Gy RT - Experimental
60 Gy RT + Cetuximab - Experimental
74 Gy RT + Cetuximab - Experimental
Secondary IDCDR0000564240
PubMed (PMID)31841363
26606200
25601342
Collaborator(s)National Cancer Institute (NCI)
North Central Cancer Treatment Group
Cancer and Leukemia Group B
NRG Oncology
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00533949-D3
Data DictionaryNCT00533949-D3-Data-Dictionary.pdf
DATANCT00533949-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00533949-D2
Data DictionaryNCT00533949-D2-Data-Dictionary.pdf
DATANCT00533949-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00533949-D1
Data DictionaryNCT00533949-D1-Data-Dictionary.pdf
DATANCT00533949-D1-Dataset.csv
OTHERREADME.pdf
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