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

NCT03451643 | Unknown

• 1 other identifier: 1010236
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Colorectal Neoplasm

Keywords

colorectal cancer; liver metastases; stage IV

Outcome Measures

Primary Outcomes (3)

• MORTALITY

  THE NUMBER OF POSTPROCEDURAL DEATHS

  60 DAYS

• SURVIVAL

  SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL

  5 YEARS

• POSTOPERATIVE MORBIDITY

  MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE

  60 DAYS

Secondary Outcomes (1)

• QUALITY OF LIFE

  5 YEARS

Study Arms (2)

Endoscopic Expandable Stent

EXPERIMENTAL

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

Colorectal Resection

ACTIVE COMPARATOR

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

Interventions

ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT PROCEDURE

PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT

Also known as: CHEMOTHERAPY

Colorectal Resection; Endoscopic Expandable Stent

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients considered at high risk for colorectal resection

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

Istituto Pietro Valdoni

Rome, 00167, Italy

RECRUITING

University of Rome Sapienza

Rome, 00167, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• antonietta lamazza, MD

  University of Rome

  STUDY DIRECTOR

Central Study Contacts

ANTONIO STERPETTI, MD

CONTACT

39-6-49972188; antonio.sterpetti@uniroma1.it

ENRICO FIORI, MD

CONTACT

39-6-49972245; enrico.fiori@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AGGREGATE PROFESSOR OF SURGERY

Model Details: RANDOMIZED CONTROLLED TRIAL

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: March 2, 2018
• Study Start: February 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2020
• Last Updated: March 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 10.02.2018 for 3 months
• Access Criteria: contact by e-mail

Locations

IT (2)