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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01721954
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : October 22, 2019
Last Update Posted : November 5, 2019
Information provided by (Responsible Party):
Sirtex Medical

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: FOLFOX6m Device: SIR-Spheres microspheres Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : December 23, 2016
Actual Study Completion Date : February 28, 2017

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01721954

Hide Hide 83 study locations
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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Florida
Orlando Health
Orlando, Florida, United States, 32806
Memorial Healthcare
Pembroke Pines, Florida, United States, 33028
United States, Illinois
University of Illinois Chicago
Chicago, Illinois, United States, 60607
Adventist Midwest Health
Hinsdale, Illinois, United States, 60521
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
Lenox Hill Hospital
New York, New York, United States, 10075
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Spartanburg Regional Healthcare / Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Methodist Hospital Dallas
Dallas, Texas, United States, 75203
United States, Utah
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
United States, West Virginia
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
Border Medical Oncology Research Unit
Albury, New South Wales, Australia, 2640
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Gold Coast Health Services District
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Monash Medical Centre
Bentleigh East, Victoria, Australia, 3165
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Western Hospital
Footscray, Victoria, Australia, 3011
Peninsula Oncology Centre
Frankston, Victoria, Australia, 3199
South Eastern Hospital
Noble Park, Victoria, Australia, 3174
Maroondah Hospital
Ringwood East, Victoria, Australia, 3135
Australia, Western Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
OL Vrouw Ziekenhuis
Aalst, Belgium, 9300
Institut Jules Bordet
Brussels, Belgium, 1000
University of Antwerp
Edegem, Belgium, 2650
Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie
Gent, Belgium, 1K12IE
AZ Maria Middelaress
Gent, Belgium, 9000
CHU Sart Tilman
Liege, Belgium, 4000
CHU Amiens
Amiens Cedex 1, France, 80054
Centre Hospitalier General de Longjumeau
Clichy Cedex, France, 92118
Hopital Beaujon
Clichy Cedex, France, 92118
Hopital Albert Michallon - Grenoble
Grenoble Cedex 9, France, 38043
Hopital Europeen Georges Pompidou
Paris, France, 75015
CHU de Bordeaux - Hopital Saint Andre
Pessac, France, 33604
CHU de Poitiers, Pole regional de cancerologie
Poitiers cedex, France, 86021
Centre Eugene Marquis
Rennes Cedex, France, 35042
Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie
Berlin, Germany, 12351
SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie
Heilbronn, Germany, 74078
Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin
Karlsruhe, Germany, 76133
Schwerpunktpraxix fur Hamatologie und Onkologie
Magdeburg, Germany, 39104
Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin
Magdeburg, Germany, 39120
Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie
Magdeburg, Germany, 39130
Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie
Marburg, Germany, 35043
St. Franziskus Hospital Muenster
Muenster, Germany, 48145
Klinikum rechts der Isar der TU Munchen Medizinische Klinik II
Munchen, Germany, 81675
Klinikum der Universitat Munchen
Munich, Germany, 81377
Rambam Medical Center
Haifa, Israel, 31096
Shaare-Zedek Medical Center
Jerusalem, Israel, 91031
Hadassah Medical Center
Jerusalem, Israel, 91120
TA Sourasky Medical Center, Oncology Department 6
Tel Aviv, Israel, 64239
Sheba Medical Center - Governmental Hospital - Oncology Division
Tel Hashomer, Israel, 56261
Ospedale Regionale U. Parini
Aosta, Italy, 11100
Dipartimento di Oncologia, Ospendali Riuniti di Bergamo
Bergamo, Italy, 24127
A.O.U. die Bologna
Bologna, Italy, 40138
Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo
Cuneo, Italy, 12100
U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello
Pisa, Italy, 56124
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
New Zealand
Wellington Hospital
Newtown, Wellington, New Zealand, 6021
Dunedin Hospital
Dunedin, New Zealand, 9016
Auckland University
Grafton, New Zealand, 1023
Regional Cancer Treatment Service
Palmerston North, New Zealand, 4414
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, Portugal, 4200-072
National Cancer Centre Singapore
Singapore, Singapore, 169610
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain, 28222
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
National Taiwan University Hospital
Taipei, Taiwan, 10048
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Sirtex Medical
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sirtex Medical Identifier: NCT01721954    
Other Study ID Numbers: STX0112
First Posted: November 6, 2012    Key Record Dates
Results First Posted: October 22, 2019
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sirtex Medical:
metastatic colorectal cancer
liver metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases