FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
NCT ID: NCT01721954
Last Updated: 2019-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
209 participants
INTERVENTIONAL
2013-05-01
2017-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
FOLFOX6m
Experimental Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
FOLFOX6m
SIR-Spheres microspheres
Interventions
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FOLFOX6m
SIR-Spheres microspheres
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sirtex Medical
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
Orlando Health
Orlando, Florida, United States
Memorial Healthcare
Pembroke Pines, Florida, United States
University of Illinois Chicago
Chicago, Illinois, United States
Adventist Midwest Health
Hinsdale, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Lenox Hill Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Spartanburg Regional Healthcare / Gibbs Cancer Center
Spartanburg, South Carolina, United States
Methodist Hospital Dallas
Dallas, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Gold Coast Health Services District
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Hobart Hospital
Hobart, Tasmania, Australia
Monash Medical Centre
Bentleigh East, Victoria, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Peninsula Oncology Centre
Frankston, Victoria, Australia
South Eastern Hospital
Noble Park, Victoria, Australia
Maroondah Hospital
Ringwood East, Victoria, Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
OL Vrouw Ziekenhuis
Aalst, , Belgium
Institut Jules Bordet
Brussels, , Belgium
University of Antwerp
Edegem, , Belgium
Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie
Ghent, , Belgium
AZ Maria Middelaress
Ghent, , Belgium
CHU Sart Tilman
Liège, , Belgium
CHU Amiens
Amiens, , France
Centre Hospitalier General de Longjumeau
Clichy, , France
Hopital Beaujon
Clichy, , France
Hopital Albert Michallon - Grenoble
Grenoble, , France
Hopital Europeen Georges Pompidou
Paris, , France
CHU de Bordeaux - Hopital Saint Andre
Pessac, , France
CHU de Poitiers, Pole regional de cancerologie
Poitiers, , France
Centre Eugene Marquis
Rennes, , France
Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie
Berlin, , Germany
SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie
Heilbronn, , Germany
Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin
Karlsruhe, , Germany
Schwerpunktpraxix fur Hamatologie und Onkologie
Magdeburg, , Germany
Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin
Magdeburg, , Germany
Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie
Magdeburg, , Germany
Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie
Marburg, , Germany
Klinikum der Universitat Munchen
Munich, , Germany
Klinikum rechts der Isar der TU Munchen Medizinische Klinik II
München, , Germany
St. Franziskus Hospital Muenster
Münster, , Germany
Rambam Medical Center
Haifa, , Israel
Shaare-Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center
Jerusalem, , Israel
TA Sourasky Medical Center, Oncology Department 6
Tel Aviv, , Israel
Sheba Medical Center - Governmental Hospital - Oncology Division
Tel Litwinsky, , Israel
Ospedale Regionale U. Parini
Aosta, , Italy
Dipartimento di Oncologia, Ospendali Riuniti di Bergamo
Bergamo, , Italy
A.O.U. die Bologna
Bologna, , Italy
Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo
Cuneo, , Italy
U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello
Pisa, , Italy
Wellington Hospital
Newtown, Wellington Region, New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Auckland University
Grafton, , New Zealand
Regional Cancer Treatment Service
Palmerston North, , New Zealand
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, , Portugal
National Cancer Centre Singapore
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22.
Wolstenholme J, Fusco F, Gray AM, Moschandreas J, Virdee PS, Love S, Van Hazel G, Gibbs P, Wasan HS, Sharma RA. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer. Int J Cancer. 2020 Aug 15;147(4):1078-1085. doi: 10.1002/ijc.32828. Epub 2020 Jan 9.
Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators; van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.
Virdee PS, Moschandreas J, Gebski V, Love SB, Francis EA, Wasan HS, van Hazel G, Gibbs P, Sharma RA. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. JMIR Res Protoc. 2017 Mar 28;6(3):e43. doi: 10.2196/resprot.7201.
Other Identifiers
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STX0112
Identifier Type: -
Identifier Source: org_study_id
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