Clinical Trials Directory

Trials / Completed

CompletedNCT04039360

SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer

Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer

Status
Completed
Phase
Study type
Observational
Enrollment
11 (actual)
Sponsor
Beijing Chao Yang Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers

Summary

This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

Detailed description

Stoma is reported to be frequent in self-expanding metallic stent (SEMS) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. Retrospective study reported worse overall survival with SEMS and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. In practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). The patients with obstructing left-sided colon cancer received SEMS treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTself-expanding metallic stent placement followed by neoadjuvant chemotherapyNeoadjuvant chemotherapy was administered 1 week after successful SEMS placement and decompression for patient with obstructing left-sided colonic cancer. Patients received either three cycles of mFOLFOX6 repeated every 2 weeks or two cycles of CAPOX repeated every 3 weeks. Elective surgery was performed 2 weeks after completion of chemotherapy by experienced colorectal surgeons.

Timeline

Start date
2014-05-01
Primary completion
2015-11-30
Completion
2015-11-30
First posted
2019-07-31
Last updated
2019-07-31

Source: ClinicalTrials.gov record NCT04039360. Inclusion in this directory is not an endorsement.