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Trial record 1 of 1 for:    STX0112
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FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT01721954
First received: October 26, 2012
Last updated: August 30, 2016
Last verified: August 2016
  Purpose

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 Intervention Phase
Colorectal Cancer Metastatic
Drug: FOLFOX6m
Device: SIR-Spheres microspheres
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: 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

Resource links provided by NLM:


Further study details as provided by Sirtex Medical:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Time of randomization for an average of two years. ] [ Designated as safety issue: No ]
    To compare the effectiveness of treatment with SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone in terms of overall survival.


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Date of randomization for an average of 12 months. ] [ Designated as safety issue: No ]
    To compare the effectiveness of SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone.


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721954

  Hide Study Locations
Locations
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
Belgium
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
France
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
Germany
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
Israel
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
Italy
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
Dunedin Hospital
Dunedin, New Zealand, 9016
Auckland University
Grafton, New Zealand, 1023
Wellington Hospital
Newtown, Wellington, New Zealand, 6021
Regional Cancer Treatment Service
Palmerston North, New Zealand, 4414
Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, Portugal, 4200-072
Singapore
National Cancer Centre Singapore
Singapore, Singapore, 169610
Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain, 28222
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10048
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Sirtex Medical
  More Information

Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT01721954     History of Changes
Other Study ID Numbers: STX0112 
Study First Received: October 26, 2012
Last Updated: August 30, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Sirtex Medical:
colon
rectum
metastatic colorectal cancer
liver metastases

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

ClinicalTrials.gov processed this record on December 05, 2016