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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
2008-12
NCT00143455Uploaded 06-29-2020
Available for Download
PDS UID: LungSm_Pfizer_2002_419
Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer
Provider Information
Provider Data DescriptionPRIMARY: To compare the effects of irinotecan hydrochloride with cisplatin to the ?standard? regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed ED-SCLC; SECONDARY: 1. To compare the overall response rate, the duration of response and the time to progression between the two treatment regimens, 2. To compare the safety of the two treatment regimens, 3. To compare the quality of life of patients treated with the two regimens, utilizing the EORTC quality of life scale, 4. To compare the tumor-related symptoms (pain, dyspnea and the use of opioids and non-opioids analgesics).
SponsorPfizer
Data ProviderPfizer
Partial set or SubsetOriginal Data
Patients in dataset485
# of Patients Control243
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/231x-9g29
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryTo compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).
ConditionsSmall Cell Lung Carcinoma
Intervention TypeDrug: Etoposide + cisplatin
Drug: Irinotecan + cisplatin
Drug(s)Drug: Etoposide + cisplatin
Drug: Irinotecan + cisplatin
Total Enrolled485
RandomizationRandomized
Blinding MethodNone
Arms InterventionB - Experimental
A - Experimental
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)Austria
Belgium
Czech Republic
Egypt
France
Germany
Italy
Netherlands
Poland
Russian Federation
Spain
Switzerland
Taiwan
Age Range18 Years to 75 Years (ADULT, OLDER_ADULT)
Files:
PROTOCOLXRP4174D-3001 Protocol Amendment 5 15 December 2004_Redacted.pdf
CRFNCT00143455_CRF_README.docx
DATA DICTIONARYPDS_DATA_PROFILE_CREATED_419.xlsx
DATA (COMPARATOR ARM)XRP4174D-3001_cohort1_CSVfiles.zip
DATA (COMPARATOR ARM)XRP4174D-3001_cohort1_SAS7BDATfiles.zip
DATA (COMPARATOR ARM)XRP4174D-3001_cohort2_CSVfiles.zip
DATA (COMPARATOR ARM)XRP4174D-3001_cohort2_SAS7BDATfiles.zip
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