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
About this trial
This is an interventional treatment trial for Colorectal Neoplasm focused on measuring colorectal cancer, liver metastases, stage IV
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
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
NCT ID
NCT03451643
First Posted
April 27, 2017
Last Updated
March 2, 2018
Sponsor
University of Roma La Sapienza
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
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