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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2004
NCT00079274Uploaded 08-10-2017
Available for Download
PDS UID: Colorec_Allianc_2004_161
N/A
Provider Information
Provider Data DescriptionPrimary Objective: To compare the disease-free survival (DFS) in patients with stage III (TxN1-2M0) colon cancer who are KRAS wild-type randomized to 24 weeks of adjuvant chemotherapy with either: (1) Oxaliplatin (OXAL) + 5-fluorouracil/leucovorin (5-FU/LV) (FOLFOX) or (2) FOLFOX + C225. Secondary Objectives: I. To compare the DFS in unselected patients with stage III (TxN1-2M0) colon cancer randomized to 24 weeks of adjuvant chemotherapy with either: (1) Oxaliplatin (OXAL) + 5-fluorouracil/leucovorin (5-FU/LV) (FOLFOX) or (2) FOLFOX + C225. II. To compare the overall survival (OS) in patients with KRAS wildtype tumors, and in unselected patients with stage III (Tx, N1-2, M0) colon cancer randomized to 24 weeks of adjuvant chemotherapy with FOLFOX with or without C225. III. To assess toxicities resulting from the addition of C225 to chemotherapy. IV. To compare the quality of life, measures of patient satisfaction, nutrition, and cancer risk in patients treated with FOLFOX with or without C225, using four patient-completed questionnaires.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset3397
# of Patients Control1337
# of Patients Experimental1631
DOIhttps://doi.org/10.34949/zywx-9253
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeChemotherapy, Drug
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
Files:
PROTOCOLn0147_protocol.pdf
CRFn0147_forms.pdf
DATA DICTIONARYn0147_ddt.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)characteristic.csv
DATA (BOTH COMPARATOR AND ACTIVE ARMS)tox.csv
DATA (BOTH COMPARATOR AND ACTIVE ARMS)objectives.csv
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