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Colorectal

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

Unique Dataset IDnci-data-60
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients795RandomizationYesPubMed (PMID)14665611.00ClinicalTrial.gov IDNCT00003594ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00003594
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrugDataset TypeOther

NCI Description

The NCT00003594_D3cytox dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient, per cycle, per adverse event during treatment. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.

Clinical Trial Title

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

Trial Summary and Conditions

RATIONALE: 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.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan. Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens. Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms. Only arm II remains open to accrual. Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.) Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

Outcome Measures

Primary: time to progression [ Time Frame: Up to 5 years ] Secondary: overall survival [ Time Frame: Up to 5 years ] time to treatment failure [ Time Frame: Up to 5 years ] response rate [ Time Frame: Up to 5 years ] quality of life [ Time Frame: Up to 5 years ]

ClinicalTrial.gov

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

Available Downloads:

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

Data Dictionary: NCT00003594-D3-Data-Dictionary_1.pdf

DATA: NCT00003594-D3-Dataset_1.csv

OTHER: README.pdf