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Type(s) of Cancer
Lung (Non-Small Cell)
Study Phase
Phase 3
Study Completion Date
January 2017
NCT01041781Uploaded 04-28-2020
Access via NCI by Request
PDS UID - nci-data-408
A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer
Provider Information
Provider Data DescriptionDataset NCT01041781-D1-Dataset.csv (c30801) is one of 2 datasets associated with PubMed ID 28489511. This dataset contains information that will allow you to reproduce the baseline characteristics table and primary analysis. In Table A5, there is a typo in the median number of OS months for Celecoxib patients with COX-2 >= 2. The correct numbers should be 15.73 (11.50-18.96) and they are the same as those present on this shared dataset.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset313
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNCI standard
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.
ConditionsLung Cancer
Intervention TypeDrug: carboplatin
Drug: celecoxib
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Other: placebo
Drug(s)Drug: carboplatin
Drug: celecoxib
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Total Enrolled313
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Active Comparator
Secondary IDCALGB-30801
PubMed (PMID)28489511
30702971
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files: NCT01041781-D1
Data DictionaryNCT01041781-D1-Data-Dictionary_1.pdf
DATANCT01041781-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT01041781-D2
Data DictionaryNCT01041781-D2-Data-Dictionary_2.pdf
DATANCT01041781-D2-Dataset.csv
OTHERREADME.pdf
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