FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)

October 23, 2019 updated by: Sirtex Medical

Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study

This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Border Medical Oncology Research Unit
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Centre
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • Southport, Queensland, Australia, 4215
        • Gold Coast Health Services District
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Hobart Hospital
    • Victoria
      • Bentleigh East, Victoria, Australia, 3165
        • Monash Medical Centre
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Footscray, Victoria, Australia, 3011
        • Western Hospital
      • Frankston, Victoria, Australia, 3199
        • Peninsula Oncology Centre
      • Noble Park, Victoria, Australia, 3174
        • South Eastern Hospital
      • Ringwood East, Victoria, Australia, 3135
        • Maroondah Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • St. John of God Murdoch Hospital
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Belgium
      • Aalst, Belgium, 9300
        • OL Vrouw Ziekenhuis
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, 2650
        • University of Antwerp
      • Gent, Belgium, 1K12IE
        • Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie
      • Gent, Belgium, 9000
        • AZ Maria Middelaress
      • Liege, Belgium, 4000
        • CHU Sart Tilman
  • France
      • Amiens Cedex 1, France, 80054
        • CHU Amiens
      • Clichy Cedex, France, 92118
        • Centre Hospitalier Général de Longjumeau
      • Clichy Cedex, France, 92118
        • Hopital Beaujon
      • Grenoble Cedex 9, France, 38043
        • Hopital Albert Michallon - Grenoble
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Pessac, France, 33604
        • CHU de Bordeaux - Hopital Saint André
      • Poitiers cedex, France, 86021
        • CHU de Poitiers, Pôle Régional de Cancérologie
      • Rennes Cedex, France, 35042
        • Centre Eugène Marquis
  • Germany
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie
      • Heilbronn, Germany, 74078
        • SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie
      • Karlsruhe, Germany, 76133
        • Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin
      • Magdeburg, Germany, 39104
        • Schwerpunktpraxix fur Hamatologie und Onkologie
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin
      • Magdeburg, Germany, 39130
        • Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie
      • Marburg, Germany, 35043
        • Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie
      • Muenster, Germany, 48145
        • St. Franziskus Hospital Muenster
      • Munchen, Germany, 81675
        • Klinikum rechts der Isar der TU Munchen Medizinische Klinik II
      • Munich, Germany, 81377
        • Klinikum der Universität München
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Jerusalem, Israel, 91031
        • Shaare-Zedek Medical Center
      • Tel Aviv, Israel, 64239
        • TA Sourasky Medical Center, Oncology Department 6
      • Tel Hashomer, Israel, 56261
        • Sheba Medical Center - Governmental Hospital - Oncology Division
  • Italy
      • Aosta, Italy, 11100
        • Ospedale Regionale U. Parini
      • Bergamo, Italy, 24127
        • Dipartimento di Oncologia, Ospendali Riuniti di Bergamo
      • Bologna, Italy, 40138
        • A.O.U. die Bologna
      • Cuneo, Italy, 12100
        • Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo
      • Pisa, Italy, 56124
        • U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 137-701
        • Seoul St. Mary's Hospital
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Grafton, New Zealand, 1023
        • Auckland University
      • Palmerston North, New Zealand, 4414
        • Regional Cancer Treatment Service
    • Wellington
      • Newtown, Wellington, New Zealand, 6021
        • Wellington Hospital
  • Portugal
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
  • Spain
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
  • Taiwan
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Healthcare
    • Illinois
      • Chicago, Illinois, United States, 60607
        • University of Illinois Chicago
      • Hinsdale, Illinois, United States, 60521
        • Adventist Midwest Health
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Center
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Healthcare / Gibbs Cancer Center
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Hospital Dallas
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • St. Mark's Hospital
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Fletcher Allen Health Care
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older
  • Willing and able to provide written informed consent
  • Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
  • Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm)
  • All imaging evidence used as part of the screening process must be within 28 days
  • Suitable for either treatment regimen
  • WHO performance status 0-1
  • Adequate hematological, renal and hepatic function
  • Life expectancy of at least 3 months without any active treatment

Exclusion Criteria:

  • Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
  • Previous radiotherapy delivered to the liver
  • Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
  • Peripheral neuropathy > grade 2 (NCI-CTC)
  • Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
  • Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
  • Pregnant or breast feeding
  • Concurrent or prior history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
  • Allergy to contrast media that would preclude angiography of the hepatic arteries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
Drug: FOLFOX6m
Experimental: Experimental Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Drug: FOLFOX6m
Device: SIR-Spheres microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
OS defined as the time interval between the date of randomization and the date of death from any cause.
From date of randomization until the date of death from any cause assessed up 3 yrs 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.
PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirtex Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

December 23, 2016

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STX0112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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