CLINICAL TRIAL SUMMARY

MDACC Study No:ACOSOGZ6051 (clinicaltrials.gov NCT No: NCT00726622)
Title:A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer
Principal Investigator:George Chang
Treatment Agent:Laparoscopic Surgery; Surgical Procedure
Study Status:Closed
Study Description:The goal of this clinical research study is to compare 2 types of surgery
currently used for rectal cancer. The 2 types of surgery are called
laparoscopic-assisted rectal resection (LARR) and open laparotomy rectal
resection (OLRR).

Researchers will compare the safety and effectiveness of the surgeries
(including the doctors' ability to remove the entire tumor, the doctor's
ability to remove the right amount of surrounding tissue, and the amount of
blood lost during surgery). Your recovery from surgery in the hospital will be
monitored, including the amount of pain medication you need, the length of your
hospital stay, and the nature of any surgical complications (problems). Your
overall recovery from surgery, general quality of life, sexual function, and
bowel function will be studied. Researchers will also check to find out if the
cancer comes back in the pelvis or other parts of the body.

Hide details for General InformationGeneral Information

Disease Group:Rectum
Phase of Study:Phase III
Treatment Agents:Laparoscopic Surgery
Surgical Procedure
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:N/A
Supported By:American College of Surgeons Oncology Group
Return Visit:Return day 3, week 1-2, week 4-6, then 3, 6, 9, 12, 18 and 24 months. Then
yearly up to year 5.
Home Care:N/A


Hide details for Study Contact InformationStudy Contact Information

Physician Name:George Chang
Dept:Surgical Oncology
For Clinical Trial Enrollment:713-563-1875
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults