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

Complication of Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039360
• Other study ID #: SEMS-NCS-01
• Status: Completed
• Start date: May 1, 2014
• Est. completion date: November 30, 2015

Study information

• Verified date: July 2019
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Complication of Treatment

Intervention

Combination Product:
• self-expanding metallic stent placement followed by neoadjuvant chemotherapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stoma rate	stoma rate after surgery	3 years after operation