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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:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
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Colorectal

A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum

Unique Dataset IDnci-data-403ClinicalTrial.gov IDNCT00265850
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients2334RandomizationYesPubMed (PMID)28632865.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeBiologics, DrugDataset TypeOther

Clinical Trial Title

A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum

Trial Summary and Conditions

PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.

Data Summary

See Data Dictionary.

Study Objectives

Primary Objective: To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer who have K-ras wild type tumors. Secondary Objectives: To evaluate response, progression-free survival (PFS), time to treatment failure (TTF), and duration of response (DR) among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX; To evaluate toxicity and, in particular, 60-day mortality among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX; To describe patients with unresectable locally advanced or metastatic colorectal cancer rendered "resectable" with chemotherapy

Outcome Measures

Primary: Overall Survival; Secondary: Progression-Free Survival (PFS), Time to Treatment Failure (TTF), Duration of Tumor Response

ClinicalTrial.gov

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

NCI Description

Dataset NCT00265850-D6-Dataset.csv (table2) is one of 8 datasets associated with PubMed ID 28632865. This dataset contains information that will allow you to reproduce table 2 of the manuscript.

Available Downloads: NCT00265850-D6

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

Data Dictionary: NCT00265850-D6-Data-Dictionary.pdf

DATA: NCT00265850-D6-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265850-D5

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

Data Dictionary: NCT00265850-D5-Data-Dictionary.pdf

DATA: NCT00265850-D5-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265850-D4

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

Data Dictionary: NCT00265850-D4-Data-Dictionary.pdf

DATA: NCT00265850-D4-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265850-D3

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

Data Dictionary: NCT00265850-D3-Data-Dictionary.pdf

DATA: NCT00265850-D3-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265850-D2

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

Data Dictionary: NCT00265850-D2-Data-Dictionary.pdf

DATA: NCT00265850-D2-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265850-D1

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

Data Dictionary: NCT00265850-D1-Data-Dictionary.pdf

DATA: NCT00265850-D1-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265850-D7

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

Data Dictionary: NCT00265850-D7-Data-Dictionary.pdf

DATA: NCT00265850-D7-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00265850-D8

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

Data Dictionary: NCT00265850-D8-Data-Dictionary.pdf

DATA: NCT00265850-D8-Dataset.csv

OTHER: README.pdf