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Colorectal

A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER

Unique Data Set IDColorec_Allianc_1994_201
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients871Comparator (Control) Arm Enrolled Patients0Experimental (Active) Arm Enrolled Patients871RandomizationYesClinicalTrial.gov IDNCT00002575ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00002575
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeSurgeryData Set TypeADS

Clinical Trial Title

A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER

Trial Summary and Conditions

This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms. The extent of colon resection is identical for both arms.

Data Summary

Experimental arm data files include data on efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

OBJECTIVES: -Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy. -Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients. -Compare the differences in costs and cost effectiveness between these treatments in this patient population. -Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)

Outcome Measures

Primary Outcome Measures: ?Disease-free survival [ Time Frame: Up to 8 years ] -Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy. -Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients. -Compare the differences in costs and cost effectiveness between these treatments in this patient population. -Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99) -Overall survival [ Time Frame: Up to 8 years ] Secondary Outcome Measures: ?Morbidity [ Time Frame: Up to 8 years ] -Mortality [ Time Frame: At 30 days ] -Costs and cost effectiveness between these treatments in this patient population [ Time Frame: Up to 8 years ] -Compare the differences in quality of life of patients treated with these regimens [ Time Frame: Up to 8 years ]

Available Downloads:

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

PROTOCOL: int-0146_Protocol.pdf

CRF: int-0146_CRFs.pdf

DATA DICTIONARY: int-0146_datadictionary.pdf

DATA (ACTIVE ARM): master.csv