EPOCH trial design

Interventional Oncology

EPOCH Trial

CANCER THERAPIES
IO SOLUTIONS PORTFOLIO
VIRTUAL EVENTS
LATEST EVIDENCE
CANCER THERAPIES
IO SOLUTIONS PORTFOLIO
VIRTUAL EVENTS
LATEST EVIDENCE
Interventional Radiology / Interventional Oncology / Latest Evidence / EPOCH trial design

An international, multi-centre, open-label, phase III, randomised controlled trial to study the impact of TheraSphere™ Y-90 Glass Microspheres in combination with second-line systemic chemotherapy for colorectal liver metastases (CLM)

 


Trial Information


  • Study Objective​
    • Evaluate efficacy and safety of TheraSphere in patients with metastatic colorectal cancer of the liver, who had progressed on first line chemotherapy.

 

Trial Design


  • Phase III, open label, multicentre (95 sites), prospective, 1:1 randomised trial
Trial Design
*Stratified by:
Unilobar or Bilobar Disease, KRAS Status (Mutant or Wild type, 1st Line Chemo (Irinotecan or oxaliplatin based)


Primary Endpoints


  • PFS according to RECIST 1.1 from time of randomization to disease progression or death
  • hPFS according to RECIST 1.1, from time of randomization to the date of disease progression in the liver or death


Secondary Endpoints


  • Overall Survival (OS)
  • Time to Symptomatic Progression (TTSP)
  • Objective Response Rate (ORR)
  • Disease Control Rate (DCR)
  • Quality of Life Assessment
  • Adverse Events and Reportable Serious Adverse Events
Please refer to this study by its ClinicalTrials.gov identifier (NTC number): NCT01483027
 
 
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