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

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.

Study Overview

• Status: Completed
• Conditions: Complication of Treatment
• Intervention / Treatment: Combination product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy

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.

• Study Type: Observational
• Enrollment (Actual): 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

11 patients included seven (63.6%) men and four (36.4%) women. The median age of the patients was 67 years (range, 43-72 years)

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. history of any other cancer
2. multiple primary colorectal cancers
3. distant metastases
4. hereditary nonpolyposis colorectal cancer
5. familial adenomatous polyposis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stoma rate	stoma rate after surgery	3 years after operation

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ACTUAL): November 30, 2015
• Study Completion (ACTUAL): November 30, 2015

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (ACTUAL): July 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Neoadjuvant chemotherapy; Stoma; Left-sided colonic tumor; Intestinal obstruction; Self-expanding metallic stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: SEMS-NCS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No