Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Cancer Metastatic
• Interventions: Device: TheraSphere

• Registration Number: NCT01483027
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Study Start: 2012-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Results First Submitted: 2021-09-01
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Results First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	TheraSphere	Standard of care second-line chemotherapy plus TheraSphere

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	From date of randomization until the date of first documented progression, as defined by RECIST 1:1 or date of death from any cause, whichever comes first, assessed up to a minimum of 1 year follow up or until study completion	Progression Free survival by blinded independent central review per RECIST 1.1
Hepatic Progression-Free Survival (HPFS)	Time from randomization until hepatic PD by BICR per RECIST 1.1 or death, whichever occurs first, assessed up to a minimum of 1 year follow up or study completion.	Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time from date of randomization until date of death due to any cause; patients remaining on study post progression were followed until study completion; duration of follow up could be a few months to several years depending on when event was met.	Time from randomization until date of death due to any cause as reported by study site.

Trial Locations

Locations (131)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California San Fransico, Moffitt Hospital; 🇺🇸 San Francisco, California, United States

University of Colorado Denver Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Christiana Care Hospital; 🇺🇸 Newark, Delaware, United States

Lynn Clinical Research Center, Boca Raton Regional Hospital; 🇺🇸 Boca Raton, Florida, United States

University of Miami Miller School of Medicine, Florida; 🇺🇸 Miami, Florida, United States

Moffit Cancer Center; 🇺🇸 Tampa, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Carle Clinic; 🇺🇸 Urbana, Illinois, United States

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