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

Unique Dataset IDNCT00726622
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients486RandomizationYesPubMed (PMID)26441179.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeSurgeryDataset TypeOther

NCI Description

This dataset will allow users to reproduce the analysis for the primary publication in trial NCT00726622. This dataset is identical to NCT00726622-D1 except it also includes a patient reference (patref) field that can be tied to patient information submitted to NCTN Navigator submissions.

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

This is a multicenter study. Patients eligible for this trial will have completed 5FU based neoadjuvant chemotherapy/radiation therapy per the institution's standard of care or IRB approved clinical trial. Patients may be registered/randomized anytime after completion of neoadjuvant therapy, but surgery must occur within 4-12 weeks (28-84 days) after completion of neoadjuvant therapy. Patients are stratified according to the site of the primary tumor (high, middle or low rectum), registering surgeon, and planned operative procedure (low anterior resection or abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more details. The primary and secondary objectives are listed below. Primary Objective: To test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection, based on a composite primary endpoint of oncologic factors which are indicative of a safe and feasible operation. Secondary Objectives: To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs. open rectal resection (blood loss, length of stay, pain medicine utilization) To assess disease free survival and local pelvic recurrence at two years. To assess quality of life, sexual function, bowel and stoma function at scheduled time points throughout the trial. Patients will be evaluated after surgery to determine the need for subsequent care based on the final pathology. Patients should not start treatment on any other investigative trial involving intervention or invasive diagnostic procedures less than or equal to 30 days following surgery to enable a complete evaluation of post-operative adverse events and complications occurring within 30 days of surgery. Patients are followed periodically for up to 5 years post surgery.

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 ]

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

Available Downloads:

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Data Dictionary: NCT00726622-D2-Data-Dictionary.pdf

DATA: NCT00726622-D2-Dataset.csv