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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Colorectal

A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer

Unique Dataset IDnci-data-407ClinicalTrial.gov IDNCT00079274
DownloadableNo
SponsorNational Cancer InstituteData ProviderNational Cancer InstituteTotal Study Enrolled Patients3397RandomizationYesPubMed (PMID)22474202.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeBiologics, Drug, ChemotherapyDataset TypeOther

Clinical Trial Title

A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer

Trial Summary and Conditions

This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors.

Data Summary

See Data Dictionary.

Study Objectives

PRIMARY OBJECTIVES: I. Disease-free Survival (Arms A and D: Wild-type KRAS Patients). SECONDARY OBJECTIVES: I. Disease-free Survival (Arms A and D: Mutant KRAS Patients); II. Disease-free Survival; III. Overall Survival; IV. Toxicity.

Outcome Measures

Primary: 1. Disease-free Survival (Arms A and D: Wild-type KRAS Patients). Secondary: 1. Disease-free Survival (Arms A and D: Mutant KRAS Patients), Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients); 2. Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients); 3. Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients); 4. Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients); 5. Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Mutant KRAS Patients).

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

The NCT00079274-D1-Dataset.csv dataset is one of 3 datasets associated with PubMed ID 22474202. This dataset contains information on baseline characteristics, eligibility, and follow-up status.

Available Downloads: NCT00079274-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00079274-D1-Data-Dictionary.pdf

DATA: NCT00079274-D1-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00079274-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00079274-D2-Data-Dictionary.pdf

DATA: NCT00079274-D2-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00079274-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00079274-D3-Data-Dictionary.pdf

DATA: NCT00079274-D3-Dataset.csv

OTHER: README.pdf