search
Back to results

Stenting and Resection for Stage IV Colorectal Cancer Endoscopic Stenting and Colorectal Resection in Stage IV

Primary Purpose

Colorectal Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasm focused on measuring colorectal cancer, liver metastases, stage IV

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Patients with Stage IV obstructing colorectal cancer and liver metastases
  • Liver metastases not resectable

Exclusion criteria

-Patients considered at high risk for colorectal resection

Sites / Locations

  • Istituto Pietro ValdoniRecruiting
  • University of Rome SapienzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic Expandable Stent

Colorectal Resection

Arm Description

Procedure/Surgery. Endeosocpically a self-expandable metal stent will be placed in the colon rectum. Chemotherapy will be added

Procedure/Surgery. A standard open or laparoscopic surgery will be performed to remove the colorectal cancer. Chemotherapy will be added

Outcomes

Primary Outcome Measures

MORTALITY
THE NUMBER OF POSTPROCEDURAL DEATHS
SURVIVAL
SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL
POSTOPERATIVE MORBIDITY
MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE

Secondary Outcome Measures

QUALITY OF LIFE
QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL

Full Information

First Posted
April 27, 2017
Last Updated
March 2, 2018
Sponsor
University of Roma La Sapienza
search

1. Study Identification

Unique Protocol Identification Number
NCT03451643
Brief Title
Stenting and Resection for Stage IV Colorectal Cancer Endoscopic Stenting and Colorectal Resection in Stage IV
Official Title
Comparison Between Endoscopic Stenting and Colorectal Resection in Patients With Stage IV Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with Stage IV obstructing colorectal cancer and unresectable liver metastses, with general and local conditions not a risk for coliorectal resection, will be randomized to have either endoscopic stenting or colorectal resection
Detailed Description
Patients with obstructing colorectal cancer, Stage IV with not resectable metastases will be considered . Patients with acceptable general and local conditions, to allow a safe surgical resection will be considered. Patients will be randomized to have endoscopic stenting or colorectal resection. All patients will receive postoperative chemio therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm
Keywords
colorectal cancer, liver metastases, stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CONTROLLED TRIAL
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Expandable Stent
Arm Type
Experimental
Arm Description
Procedure/Surgery. Endeosocpically a self-expandable metal stent will be placed in the colon rectum. Chemotherapy will be added
Arm Title
Colorectal Resection
Arm Type
Active Comparator
Arm Description
Procedure/Surgery. A standard open or laparoscopic surgery will be performed to remove the colorectal cancer. Chemotherapy will be added
Intervention Type
Procedure
Intervention Name(s)
ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT
Other Intervention Name(s)
CHEMOTHERAPY
Intervention Description
PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT
Primary Outcome Measure Information:
Title
MORTALITY
Description
THE NUMBER OF POSTPROCEDURAL DEATHS
Time Frame
60 DAYS
Title
SURVIVAL
Description
SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL
Time Frame
5 YEARS
Title
POSTOPERATIVE MORBIDITY
Description
MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE
Time Frame
60 DAYS
Secondary Outcome Measure Information:
Title
QUALITY OF LIFE
Description
QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL
Time Frame
5 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients with Stage IV obstructing colorectal cancer and liver metastases Liver metastases not resectable Exclusion criteria -Patients considered at high risk for colorectal resection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANTONIO STERPETTI, MD
Phone
39-6-49972188
Email
antonio.sterpetti@uniroma1.it
First Name & Middle Initial & Last Name or Official Title & Degree
ENRICO FIORI, MD
Phone
39-6-49972245
Email
enrico.fiori@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
antonietta lamazza, MD
Organizational Affiliation
University of Rome
Official's Role
Study Director
Facility Information:
Facility Name
Istituto Pietro Valdoni
City
Rome
ZIP/Postal Code
00167
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ENRICO FIORI, MD
Phone
39-6-49972245
Email
enrico.fiori@uniroma1.it
Facility Name
University of Rome Sapienza
City
Rome
ZIP/Postal Code
00167
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO STERPETTI, MD
Phone
39-6-49972188
Email
antonio.sterpetti@uniroma1.it

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD data will be shared with publications and conferebnces
IPD Sharing Time Frame
10.02.2018 for 3 months
IPD Sharing Access Criteria
contact by e-mail

Learn more about this trial

Stenting and Resection for Stage IV Colorectal Cancer Endoscopic Stenting and Colorectal Resection in Stage IV

We'll reach out to this number within 24 hrs