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

March 2, 2018 updated by: antonio sterpetti, University of Roma La Sapienza

Comparison Between Endoscopic Stenting and Colorectal Resection in Patients With Stage IV Colorectal Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00167
        • Recruiting
        • Istituto Pietro Valdoni
        • Contact:
      • Rome, Italy, 00167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic Expandable Stent
Procedure/Surgery. Endeosocpically a self-expandable metal stent will be placed in the colon rectum. Chemotherapy will be added
Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT
PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT
Other Names:
  • CHEMOTHERAPY
Active Comparator: Colorectal Resection
Procedure/Surgery. A standard open or laparoscopic surgery will be performed to remove the colorectal cancer. Chemotherapy will be added
Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT
PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT
Other Names:
  • CHEMOTHERAPY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MORTALITY
Time Frame: 60 DAYS
THE NUMBER OF POSTPROCEDURAL DEATHS
60 DAYS
SURVIVAL
Time Frame: 5 YEARS
SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL
5 YEARS
POSTOPERATIVE MORBIDITY
Time Frame: 60 DAYS
MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE
60 DAYS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QUALITY OF LIFE
Time Frame: 5 YEARS
QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL
5 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Study Director: antonietta lamazza, MD, University of Rome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1010236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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