SEMS Placement Followed by Chemotherapy and Surgery for O... | NCT04039360

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

NCT04039360

Sponsor

Beijing Chao Yang Hospital

Status

Completed

Last Update Posted

Jul 31, 2019Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Complication of Treatment

Interventions

self-expanding metallic stent placement followed by neoadjuvant chemotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2014Actual

Primary Completion Date

Nov 30, 2015Actual

Completion Date

Nov 30, 2015Actual

First Submitted Date

Jul 27, 2019

First Submission Date that Met QC Criteria

Jul 30, 2019

First Posted Date

Jul 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2019

Last Update Posted Date

Jul 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007415	Intestinal Obstruction

Ancestor Terms

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided