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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
June 2005
NCT00003299Uploaded 07-30-2018
Available for Download
PDS UID: LungSm_Allianc_1998_261
A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer
Provider Information
Provider Data DescriptionI. Determine whether the addition of paclitaxel to standard chemotherapy treatment comprising etoposide and cisplatin improves the survival of patients with extensive stage small cell lung cancer. II. Compare the tumor response rate and failure-free survival of these patients treated with these regimens. III. Describe and compare the toxic effects associated with these regimens in these patients.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetN/A
Patients in dataset587
# of Patients Control294
# of Patients Experimental293
DOIhttps://doi.org/10.34949/bhrq-ca29
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.
ConditionsLung Cancer
Intervention TypeDrug: cisplatin
Drug: etoposide
Drug: paclitaxel
Drug(s)Drug: cisplatin
Drug: etoposide
Drug: paclitaxel
Total Enrolled587
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCisplatin + Etoposide - Active Comparator
Cisplatin + Etoposide + Paclitaxel - Experimental
Secondary IDU10CA031946
PubMed (PMID)16365181
15923572
Collaborator(s)National Cancer Institute (NCI)
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
Southwest Oncology Group
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLC9732_protocol.pdf
CRFC9732_CRFs.pdf
DATA DICTIONARYC9732_Dictionary.xlsx
DATA (BOTH COMPARATOR AND ACTIVE ARMS)c9732_ae.sas7bdat
DATA (BOTH COMPARATOR AND ACTIVE ARMS)c9732_demographic.sas7bdat
OTHERc9732_fmt.sas7bdat
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