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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2004-10
NCT00003594Uploaded 07-13-2018
Access via NCI by Request
PDS UID: nci-data-369
A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum
Provider Information
Provider Data DescriptionThe NCT00003594_D4end_at dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient regarding end of treatment timing and reason. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
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 which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.
ConditionsColorectal Cancer
Intervention TypeDrug: irinotecan
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug(s)Drug: irinotecan
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Total Enrolled1691
RandomizationRandomized
Blinding MethodNone
Arms Interventionirinotecan + leucovorin + fluorouracil - Experimental
oxaliplatin + leucovorin + fluorouracil - Experimental
oxaliplatin + irinotecan - Experimental
Secondary IDCDR0000066665
PubMed (PMID)22162570
21880789
18182660
11204663
21632455
21422438
20697547
20530282
19828593
19636001
19073970
19001325
17687151
16849748
15677624
15470715
14665611
31104167
Collaborator(s)National Cancer Institute (NCI)
NCIC Clinical Trials Group
Region(s)United States
Canada
Puerto Rico
South Africa
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00003594-D4
Data DictionaryNCT00003594-D4-Data-Dictionary.pdf
DATANCT00003594-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00003594-D3
Data DictionaryNCT00003594-D3-Data-Dictionary.pdf
DATANCT00003594-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00003594-D2
Data DictionaryNCT00003594-D2-Data-Dictionary.pdf
DATANCT00003594-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00003594-D1
Data DictionaryNCT00003594-D1-Data-Dictionary.pdf
DATANCT00003594-D1-Dataset.csv
OTHERREADME.pdf
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