NCT02694562

Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy

Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy: A Pilot Study of Irinotecan in the Treatment of Metastatic Colorectal Carcinoma (mCRC) by Embozene TANDEM™ Drug-Eluting Microspheres Embolization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety and local tumor control of Embozene TANDEM Microspheres (40um TANDEM) loaded with Irinotecan to treat metastatic colorectal carcinoma (mCRC).

Detailed description

Colon or rectal carcinoma that has spread to the liver is considered to be metastatic and is a Stage IV cancer. If the metastasized tumor is unresectable, the only current treatment is chemotherapy. Transarterial Chemoembolization (TACE) is considered as a palliative treatment in advanced metastatic colorectal carcinoma (mCRC), with the potential of local tumor control. TACE has evolved in the past 8 years to include drug-delivery devices that can target and deliver drugs from small microparticles (DEB-TACE). Superselective DEB-TACE has the potential to penetrate deeper into the tumor's vasculature to reach peripheral growing points. Loading these microparticles with a cytotoxic drug may improve the level of local tumor control. The MIRACLE III study is a controlled, pilot, single center (Italy) study on 18 subjects with pretreated non-resectable mCRC.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
DEVICE	40um Embozene TANDEM Microspheres	40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-02-29
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

1 site across 1 country: Italy