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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 Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Unique Data Set IDnci-data-10
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNCITotal Study Enrolled Patients486RandomizationYesPubMed (PMID)26441179.00ClinicalTrial.gov IDNCT00726622ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00726622
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeProcedureData Set TypeOther

Clinical Trial Title

A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Trial Summary and Conditions

This study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.

Data Summary

See data dictionary for more details.

Study Objectives

Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation. [ Time Frame: At time of Surgery ] The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation. Primary endpoint parameters: Circumferential margin > 1 mm Negative distal margin Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat. All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.

Outcome Measures

Primary: Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation. [ Time Frame: At time of Surgery ] Primary endpoint parameters: Circumferential margin > 1 mm Negative distal margin Completeness of total mesorectal excision (TME) All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior. Secondary: Completeness of Total Mesorectal Excision (Complete or Nearly Complete) [ Time Frame: At time of surgery ] Negative Distal Resected Margin [ Time Frame: At time of surgery ] Circumferential Margin > 1 mm [ Time Frame: At time of surgery ] Length of Stay [ Time Frame: Two weeks post-surgery ] Use of Pain Medication [ Time Frame: Two weeks post-surgery ] Operative Times [ Time Frame: During surgery ] Disease-free Survival [ Time Frame: Up to 2 years post surgery ] Local Pelvic Recurrence Rates [ Time Frame: Up to 2 years post surgery ] Overall Survival [ Time Frame: Up to 5 years post surgery ] Quality of Life and Sexual Function [ Time Frame: Up to 5 years post surgery ] Bowel Function [ Time Frame: Up to 5 years post surgery ] Bowel and Stoma Function [ Time Frame: Up to 5 years post surgery ]

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: NCT00726622-D1-Data-Dictionary.pdf

DATA: NCT00726622-D1-Dataset.csv

OTHER: README.pdf