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

This study is currently recruiting participants.
Verified May 2013 by Nordion (Canada) Inc.
Sponsor:
Information provided by (Responsible Party):
Nordion (Canada) Inc.
ClinicalTrials.gov Identifier:
NCT01483027
First received: November 24, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer Metastatic
 Device: TheraSphere
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nordion (Canada) Inc.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: January 2012
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Standard of care second-line chemotherapy plus TheraSphere
 Device: TheraSphere
yttrium 90 microspheres
No Intervention: Control group
Standard of care second-line chemotherapy with no added therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal cancer with metastases progressed after first line treatment

Exclusion Criteria:

  • Contraindications to TheraSphere or second line chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483027

Contacts
Contact: Medha Kelkar, MPharm, PMP 905 403 9901 ext 2667 medha.kelkar@theoremclinical.com

  Show 19 Study Locations
Sponsors and Collaborators
Nordion (Canada) Inc.
Investigators
Principal Investigator: Mary Mulcahy, MD Northwestern University
  More Information

No publications provided

Responsible Party: Nordion (Canada) Inc.
ClinicalTrials.gov Identifier: NCT01483027     History of Changes
Other Study ID Numbers: TS-102
Study First Received: November 24, 2011
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013