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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04039360

Enrollment

Registered

2019-07-31

Start date

2014-05-01

Completion date

2015-11-30

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Treatment

Keywords

Left-sided colonic tumor, Intestinal obstruction, Self-expanding metallic stent, Neoadjuvant chemotherapy, Stoma

Brief 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.

Interventions

COMBINATION_PRODUCTself-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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
stoma rate	3 years after operation	stoma rate after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026