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

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ClinicalTrials.gov Identifier: NCT03451643
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
antonio sterpetti, University of Roma La Sapienza

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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMIZED CONTROLLED TRIAL
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Endoscopic Stenting and Colorectal Resection in Patients With Stage IV Colorectal Cancer
Actual Study Start Date : February 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: CHEMOTHERAPY




Primary Outcome Measures :
  1. MORTALITY [ Time Frame: 60 DAYS ]
    THE NUMBER OF POSTPROCEDURAL DEATHS

  2. SURVIVAL [ Time Frame: 5 YEARS ]
    SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL

  3. POSTOPERATIVE MORBIDITY [ Time Frame: 60 DAYS ]
    MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE


Secondary Outcome Measures :
  1. QUALITY OF LIFE [ Time Frame: 5 YEARS ]
    QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451643


Contacts
Contact: ANTONIO STERPETTI, MD 39-6-49972188 antonio.sterpetti@uniroma1.it
Contact: ENRICO FIORI, MD 39-6-49972245 enrico.fiori@uniroma1.it

Locations
Italy
Istituto Pietro Valdoni Recruiting
Rome, Italy, 00167
Contact: ENRICO FIORI, MD    39-6-49972245    enrico.fiori@uniroma1.it   
University of Rome Sapienza Recruiting
Rome, Italy, 00167
Contact: ANTONIO STERPETTI, MD    39-6-49972188    antonio.sterpetti@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Director: antonietta lamazza, MD University of Rome

Responsible Party: antonio sterpetti, AGGREGATE PROFESSOR OF SURGERY, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03451643     History of Changes
Other Study ID Numbers: 1010236
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD data will be shared with publications and conferebnces
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 10.02.2018 for 3 months
Access Criteria: contact by e-mail

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by antonio sterpetti, University of Roma La Sapienza:
colorectal cancer
liver metastases
stage IV

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases