NCT04039360

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

July 27, 2019

Last Update Submit

July 30, 2019

Conditions

Complication of Treatment

Keywords

Left-sided colonic tumorIntestinal obstructionSelf-expanding metallic stentNeoadjuvant chemotherapyStoma

Outcome Measures

Primary Outcomes (1)

  • stoma rate

    stoma rate after surgery

    3 years after operation

Interventions

self-expanding metallic stent placement followed by neoadjuvant chemotherapyCOMBINATION_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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of General Surgery

Study Record Dates

First Submitted

July 27, 2019

First Posted

July 31, 2019

Study Start

May 1, 2014

Primary Completion

November 30, 2015

Study Completion

November 30, 2015

Last Updated

July 31, 2019

Record last verified: 2019-07