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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 Data Set IDColorec_Allianc_1998_184
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients1691Comparator (Control) Arm Enrolled Patients429RandomizationYesClinicalTrial.gov IDNCT00003594ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/results?term=n9741&Search=Search
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, DrugData Set TypeADS

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

Control arm data files on demographics, safety, response, and treatment information. See the provided data dictionary for more details.

Study Objectives

I. The primary objective of this trial is to compare the time to progression in patients with locally advanced or metastatic colorectal cancer (previously untreated for advanced disease) who receive OXAL + 5-FU + CF or CPT-11 + OXAL (the two experimental regimens) to those receiving CPT-11 + 5-FU + CF (the control regimen). II. A secondary objective of this trial is to compare the time to progression of patients receiving the two experimental regimens. II. The primary secondary outcome measure in this trial is overall survival. III. Other secondary objectives include evaluation of toxicity, response rate, and time to treatment failure. IV. To compare quality-of-life parameters in patients on these regimens.

Outcome Measures

Primary Outcome Measures: time to progression [ Time Frame: Up to 5 years ] Secondary Outcome Measures: 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 ]

Available Downloads:

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

PROTOCOL: N9741_protocol.pdf

CRF: N9741_casereportforms.pdf

DATA DICTIONARY: N9741_ddt.docx

DATA (COMPARATOR ARM): crse.csv

DATA (COMPARATOR ARM): end_at.csv

DATA (COMPARATOR ARM): cytox.csv

DATA (COMPARATOR ARM): cycle.csv