Approximately 80 more participants are needed for a multisite, Phase 3 clinical trial comparing laparoscopic-assisted versus conventional surgery in patients with stage IIA, Stage IIIA or stage IIIB rectal cancer.?
Eligible participants must have completed their pre-surgery chemotherapy (Xelox? or fluorouracil-based) and/or pre-surgery radiation therapy within the previous 4 weeks.
Standard medical practice for rectal cancer surgery has been conventional operating techniques, but surgeons at comprehensive cancer centers around the world have been performing and studying?outcomes of laparoscopic versus traditional rectal cancer surgery for several years. The evidence so far?in most trials?shows safety and recurrence rates about equal for both types of surgery; however, it?s still too early to compare long-term survival rates.
In this U.S. study, participants will be randomly assigned to receive either conventional surgery or laparoscopic-assisted surgery. During hospitalization for the surgery, patients will be studied for surgical results (e.g., complete surgical removal of the cancer), as well as length of hospital stay and need for pain medication. For a follow-up period of several years, patients will fill out quality-of-life questionnaires (e.g., bowel, stoma, sexual function).
The trial goal is to evaluate whether laparoscopic surgery is as safe and effective as conventional surgery to remove certain stage II and III rectal cancers. Outcomes will be evaluated according to surgical success, quality of life measures, and disease-free survival and/or pelvic recurrence within 2 years, with long-term followup?for 5 years.
If you?d like more details about eligibility or participating clinical locations, call Fight Colorectal Cancer?s Answer Line at 1-877-427-2111.??
Source: ClinicalTrials.gov;??American College of Surgeons Surgery News Update Oct. 4 2011 ;???Laparoscopic Surgery for Rectal Cancer: State of the Art,? Sept. 27 2010 World Journal of Gastrointestinal Surgery?
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rld Journal of Gastrointestinal Surgery Sept. 27 2010
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