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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
October 2015
NCT00324805Uploaded 04-24-2019
Access via NCI by Request
PDS UID: nci-data-394
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)
Provider Information
Provider Data DescriptionThere are four different submissions (each with one dataset) for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D4, can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement. Dataset NCT00324805-D1 contains baseline, treatment, and efficacy data. Dataset NCT00324805-D2 contains toxicity data for duplicating the results in Table 2 of the manuscript. Dataset NCT00324805-D3 contains toxicity data for duplicating the results in Table 3 of the manuscript.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
ConditionsStage IB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Intervention TypeBiological: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
Other: Questionnaire Administration
Drug: Vinorelbine Tartrate
Drug(s)Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Drug: Pemetrexed Disodium
Drug: Vinorelbine Tartrate
Total Enrolled1501
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemotherapy) - Active Comparator
Arm II (chemotherapy, bevacizumab) - Experimental
Secondary IDNCI-2009-00509
PubMed (PMID)29129443
Collaborator(s)Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Region(s)United States
Canada
Ireland
Peru
South Africa
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00324805-D4
Data DictionaryNCT00324805-D4-Data-Dictionary.pdf
DATANCT00324805-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00324805-D3
Data DictionaryNCT00324805-D3-Data-Dictionary.pdf
DATANCT00324805-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00324805-D2
Data DictionaryNCT00324805-D2-Data-Dictionary.pdf
DATANCT00324805-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00324805-D1
Data DictionaryNCT00324805-D1-Data-Dictionary.pdf
DATANCT00324805-D1-Dataset.csv
OTHERREADME.pdf
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