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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2020-02-28
NCT01150045Uploaded 02-19-2022
Access via NCI by Request
PDS UID: nci-data-489
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
Provider Information
Provider Data DescriptionDataset NCT01150045-D1-Dataset.csv (Figure1) is one of 4 datasets associated with PubMed ID 33821899. This dataset contains the data presented in the CONSORT diagram (Figure 1) from the manuscript. The dataset has one row-per-patient.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryPURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.
ConditionsColorectal Cancer
Intervention TypeDrug: celecoxib
Drug: 5-fluorouracil
Other: placebo
Drug: oxaliplatin
Drug: leucovorin
Drug(s)Drug: 5-fluorouracil
Drug: oxaliplatin
Drug: leucovorin
Drug: celecoxib
Total Enrolled2527
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm A - FOLFOX and placebo (12 treatments) - Active Comparator
Arm B - FOLFOX and celecoxib (12 treatments) - Experimental
Arm C - FOLFOX and placebo (6 treatments) - Active Comparator
Arm D - FOLFOX and celecoxib (6 treatments) - Experimental
Secondary IDU10CA031946
PubMed (PMID)36367997
36306483
33821899
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01150045-D1
Data DictionaryNCT01150045-D1-Data-Dictionary_1.pdf
DATANCT01150045-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT01150045-D2
Data DictionaryNCT01150045-D2-Data-Dictionary_2.pdf
DATANCT01150045-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01150045-D3
Data DictionaryNCT01150045-D3-Data-Dictionary_3.pdf
DATANCT01150045-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01150045-D4
Data DictionaryNCT01150045-D4-Data-Dictionary_2.pdf
DATANCT01150045-D4-Dataset_1.csv
OTHERREADME.pdf
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