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

NCT ID: NCT03451643

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2020-02-29

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

Conditions

Colorectal Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Expandable Stent

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

Group Type: EXPERIMENTAL

ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT

Intervention Type: PROCEDURE

PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT

Colorectal Resection

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

Group Type: ACTIVE_COMPARATOR

ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT

Intervention Type: PROCEDURE

PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT

Interventions

ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT

PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT

Intervention Type: PROCEDURE

Other Intervention Names

CHEMOTHERAPY

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

antonio sterpetti

AGGREGATE PROFESSOR OF SURGERY

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

antonietta lamazza, MD

Role: STUDY_DIRECTOR

University of Rome

Locations

Istituto Pietro Valdoni

Rome, , Italy

Site Status: RECRUITING

University of Rome Sapienza

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

ANTONIO STERPETTI, MD

Role: CONTACT

antonio.sterpetti@uniroma1.it

39-6-49972188

ENRICO FIORI, MD

Role: CONTACT

enrico.fiori@uniroma1.it

39-6-49972245

Facility Contacts

ENRICO FIORI, MD

Role: primary

enrico.fiori@uniroma1.it

39-6-49972245

ANTONIO STERPETTI, MD

Role: primary

antonio.sterpetti@uniroma1.it

39-6-49972188

Other Identifiers

1010236

Identifier Type: -

Identifier Source: org_study_id