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 currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Sirtex Medical
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT01721954
First received: October 26, 2012
Last updated: September 22, 2014
Last verified: September 2014
  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: July 2018
Estimated Primary Completion Date: January 2015 (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
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

Contacts
Contact: Henk Tissing 31-26-3391124 htissing@sirtex-europe.com
Contact: Janet Bell 888-474-7839 ext 710 jbell@sirtex.com

  Hide Study Locations
Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Principal Investigator: Yi-Jen Chen, MD         
United States, Florida
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Sajeve Thomas, MD         
Memorial Healthcare Recruiting
Pembroke Pines, Florida, United States, 33028
Principal Investigator: Pablo Ferraro, MD         
United States, Illinois
University of Illinois Chicago Recruiting
Chicago, Illinois, United States, 60607
Principal Investigator: James Bui, MD         
Adventist Midwest Health Recruiting
Hinsdale, Illinois, United States, 60521
Principal Investigator: Francis Facchini, MD         
United States, Indiana
St. Vincent Health Group Withdrawn
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Principal Investigator: Dr. David Kirsch         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Navesh Sharma, DO         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Andreas Kaubisch, MD         
Roswell Park Cancer Center Recruiting
Buffalo, New York, United States, 14263
Principal Investigator: Renuka Iyer, MD         
Principal Investigator: Patrick Boland, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Principal Investigator: Dr. Mark Westcott         
Principal Investigator: Dr. Lynn Ratner         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: Eric Wang, MD         
Principal Investigator: Gary Frenette, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Matthew Holtzman, MD         
United States, South Carolina
Spartanburg Regional Healthcare / Gibbs Cancer Center Recruiting
Spartanburg, South Carolina, United States, 29303
Principal Investigator: Kyran Dowling, MD         
Principal Investigator: Charles Bowers, MD         
United States, Texas
Methodist Hospital Dallas Recruiting
Dallas, Texas, United States, 75203
Principal Investigator: Rohan Jeyarajah, MD         
United States, Utah
St. Mark's Hospital Recruiting
Salt Lake City, Utah, United States, 84124
Principal Investigator: James Carlisle, MD         
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05405
Principal Investigator: Dr. Steven Ades         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Principal Investigator: Dr. Patricia Stoltzfus         
Principal Investigator: Dr. Sobha Kurian         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Daniel Bloomgarden, MD         
Principal Investigator: Jacob Frick, MD         
Australia, New South Wales
Gosford Hospital Recruiting
Gosford, New South Wales, Australia, 2250
Principal Investigator: Dr. Susan Tiley         
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Principal Investigator: Dr. Nick Pavlakis         
Southern Medical Day Care Centre Recruiting
Wollongong, New South Wales, Australia, 2500
Principal Investigator: A/Professor Morteza Aghmesheh         
Australia, Queensland
Royal Brisbane Hospital Recruiting
Herston, Queensland, Australia, 4029
Principal Investigator: Dr. Matthew Burge         
Gold Coast Health Services District Recruiting
Southport, Queensland, Australia, 4215
Principal Investigator: Dr. Matos         
Allamanda Private Hospital Withdrawn
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Principal Investigator: Dr. Walpole         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Principal Investigator: Dr. Nimit Singhal         
Australia, Tasmania
Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Principal Investigator: Dr. Louise Nott         
Australia, Victoria
Monash Medical Centre Recruiting
Bentleigh East, Victoria, Australia, 3165
Principal Investigator: Dr. Andrew Strickland         
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Principal Investigator: Dr. Prasad Cooray         
Western Hospital Recruiting
Footscray, Victoria, Australia, 3011
Principal Investigator: Prof. Peter Gibbs         
Peninsula Oncology Centre Recruiting
Frankston, Victoria, Australia, 3199
Principal Investigator: Dr. Vinod Ganju         
South Eastern Hospital Recruiting
Noble Park, Victoria, Australia, 3174
Principal Investigator: Dr. Andrew Strickland         
Maroondah Hospital Recruiting
Ringwood East, Victoria, Australia, 3135
Principal Investigator: Dr. Lim         
Border Medical Oncology Recruiting
Wodonga, Victoria, Australia, 3690
Principal Investigator: Dr. Craig Underhill         
Australia, Western Australia
St. John of God Murdoch Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Principal Investigator: Dr. Feeney         
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Principal Investigator: Prof. van Hazel         
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Principal Investigator: Dr. Ferguson         
The Mount Hospital Recruiting
Perth, Western Australia, Australia, 6000
Principal Investigator: Prof. van Hazel         
Belgium
OL Vrouw Ziekenhuis Recruiting
Aalst, Belgium, 9300
Principal Investigator: Marc De Man         
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Principal Investigator: Prof. Amelie Deleporte         
University of Antwerp Recruiting
Edegem, Belgium, 2650
Principal Investigator: Prof. Marc Peeters         
AZ Maria Middelaress Recruiting
Gent, Belgium, 9000
Principal Investigator: Els Monsaert         
Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie Recruiting
Gent, Belgium, 1K12IE
Principal Investigator: Prof. Karen Geboes         
CHU Sart Tilman Recruiting
Liege, Belgium, 4000
Principal Investigator: Marc Polus         
France
CHU Amiens Recruiting
Amiens Cedex 1, France, 80054
Principal Investigator: Jean-Paul Joly         
Centre Hospitalier General de Longjumeau Recruiting
Clichy Cedex, France, 92118
Principal Investigator: Samy Louafi         
Hopital Beaujon Recruiting
Clichy Cedex, France, 92118
Principal Investigator: Sandrine Faivre         
Hopital Albert Michallon - Grenoble Recruiting
Grenoble Cedex 9, France, 38043
Principal Investigator: Christine Rebischung         
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Principal Investigator: Julien Taieb         
CHU de Bordeaux - Hopital Saint Andre Recruiting
Pessac, France, 33604
Principal Investigator: Denis Smith         
CHU de Poitiers, Pole regional de cancerologie Recruiting
Poitiers cedex, France, 86021
Principal Investigator: Aurelie Ferru         
Centre Eugene Marquis Recruiting
Rennes Cedex, France, 35042
Principal Investigator: Eveline Boucher         
Germany
Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie Recruiting
Berlin, Germany, 12351
Principal Investigator: Maike De Wit         
SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie Recruiting
Heilbronn, Germany, 74078
Principal Investigator: Prof. Philippe Pereira         
Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin Recruiting
Karlsruhe, Germany, 76133
Principal Investigator: Klaus Tatsch         
Schwerpunktpraxix fur Hamatologie und Onkologie Recruiting
Magdeburg, Germany, 39104
Principal Investigator: Hendrik Kroning         
Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie Recruiting
Magdeburg, Germany, 39130
Principal Investigator: Prof. Karsten Ridwelski         
Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin Recruiting
Magdeburg, Germany, 39120
Principal Investigator: Jens Ricke         
Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie Recruiting
Marburg, Germany, 35043
Principal Investigator: Jorge Riera-Knorrenschild         
St. Franziskus Hospital Muenster Recruiting
Muenster, Germany, 48145
Principal Investigator: Prof. Christoph Bremer         
Klinikum rechts der Isar der TU Munchen Medizinische Klinik II Recruiting
Munchen, Germany, 81675
Principal Investigator: Prof. Klemens Scheidhauer         
Klinikum der Universitat Munchen Recruiting
Munich, Germany, 81377
Principal Investigator: Volker Heinemann         
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Principal Investigator: Dr. Alex Beny         
Shaare-Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Thomas Tichler         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Principal Investigator: Ayala Hubert         
TA Sourasky Medical Center, Oncology Department 6 Recruiting
Tel Aviv, Israel, 64239
Principal Investigator: Ravit Geva         
Sheba Medical Center - Governmental Hospital - Oncology Division Recruiting
Tel Hashomer, Israel, 56261
Principal Investigator: Adi Shani         
Italy
Ospedale Regionale U. Parini Recruiting
Aosta, Italy, 11100
Principal Investigator: Dr. Gianmauro Numico         
Dipartimento di Oncologia, Ospendali Riuniti di Bergamo Recruiting
Bergamo, Italy, 24127
Principal Investigator: Stefania Mosconi         
A.O.U. die Bologna Recruiting
Bologna, Italy, 40138
Principal Investigator: Bruna Angelelli         
Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo Recruiting
Cuneo, Italy, 12100
Principal Investigator: Cristina Granetto         
U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello Recruiting
Pisa, Italy, 56124
Principal Investigator: Gianluca Masi         
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Principal Investigator: Prof. Kim Yeul-Hong         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Principal Investigator: Prof. Hoo Geun-Chun         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Principal Investigator: Prof. Han Sae-Won         
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Principal Investigator: Dr. Bridget Robinson         
Dunedin Hospital Recruiting
Dunedin, New Zealand, 9016
Principal Investigator: Dr. Chris Jackson         
Auckland University Recruiting
Grafton, New Zealand, 1023
Principal Investigator: Dr. Michael Findley         
Wellington Hospital Recruiting
Newtown, Wellington, New Zealand, 6021
Principal Investigator: Dr. Anne O'Donnell         
Regional Cancer Treatment Service Recruiting
Palmerston North, New Zealand, 4414
Principal Investigator: Dr. Richard Isaacs         
Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Recruiting
Porto, Portugal, 4200-072
Principal Investigator: Rosa Maria Fragoso         
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Principal Investigator: Dr. Iain Tan         
Spain
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Madrid, Spain, 28222
Principal Investigator: Ana Ruiz Casado         
Clinica Universidad de Navarra Recruiting
Pamplona, Spain, 31008
Principal Investigator: Javier Rodriguez         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain, 31008
Principal Investigator: Ruth Vera Garcia         
Taiwan
Chang Gung Memorial Hospital - Linkou Withdrawn
Linkou, Taiwan, 11217
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 10048
Principal Investigator: Dr. Jin-Tung Liang         
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan, 11217
Principal Investigator: Dr. Jin-Hwang Liu         
Sponsors and Collaborators
Sirtex Medical
  More Information

No publications provided

Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT01721954     History of Changes
Other Study ID Numbers: STX0112
Study First Received: October 26, 2012
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

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 October 01, 2014