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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complication of Treatment Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)
Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2

Exclusion criteria

history of any other cancer
multiple primary colorectal cancers
distant metastases
hereditary nonpolyposis colorectal cancer
familial adenomatous polyposis

Treatment and study plan

self-expanding metallic stent placement followed by neoadjuvant chemotherapy

Combination Product

Neoadjuvant 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.

Primary outcomes

stoma rate

Time frame: 3 years after operation

stoma rate after surgery

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jul 31, 2019
Registry last updated: Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed