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Type(s) of Cancer
Lung (Small Cell)

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 Experimental294

DOIN/A

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 RangeMinimum Age: 18 Years
Maximum Age: NA

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