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Lung (Small Cell)

A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer

Unique Dataset IDLungSm_Allianc_1998_261
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients587Comparator (Control) Arm Enrolled Patients294Experimental (Active) Arm Enrolled Patients293RandomizationYesClinicalTrial.gov IDNCT00003299ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00003299
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapyDataset TypeADS

Clinical Trial Title

A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer

Trial Summary and Conditions

RATIONALE: 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.

Data Summary

Control and experimental arm data files include data on safety, efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

I. 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.

Outcome Measures

Outcome measures are overall survival, response rate, and failure-free survival.

Available Downloads:

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

PROTOCOL: C9732_protocol.pdf

CRF: C9732_CRFs.pdf

DATA DICTIONARY: C9732_Dictionary.xlsx

DATA (BOTH COMPARATOR AND ACTIVE ARMS): c9732_ae.sas7bdat

DATA (BOTH COMPARATOR AND ACTIVE ARMS): c9732_demographic.sas7bdat

OTHER: c9732_fmt.sas7bdat