Colon Cancer Clinical Trial

FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer

Summary

This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

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 treating Investigator.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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).
Suitable for either treatment regimen.
Prior chemotherapy for metastatic colorectal cancer is not allowed.
WHO performance status 0-1.
Adequate hematological, renal and hepatic function.
Age 18 years or older.
Willing and able to provide written informed consent.
Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
Previous radiotherapy delivered to the upper abdomen.
Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
Peripheral neuropathy > grade 1 (NCI-CTC).
Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
Pregnant or breast-feeding.
Other active malignancy.

Study is for people with:

Colon Cancer

Estimated Enrollment:

530

Study ID:

NCT00724503

Recruitment Status:

Completed

Sponsor:

Sirtex Medical

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 76 Locations for this study

See Locations Near You

Pinnacle Oncology Hematology
Scottsdale Arizona, 85258, United States
City of Hope Hospital
Duarte California, 91010, United States
Florida International University College of Medicine Practice
North Miami Beach Florida, 33169, United States
Vanguard Health
Berwyn Illinois, 60402, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
Ingalls Memorial Hospital
Harvey Illinois, 80426, United States
Adventist Hinsdale Hospital
Hinsdale Illinois, 60525, United States
University of Louisville
Louisville Kentucky, 40202, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States
William Beaumont Hospital
Royal Oak Michigan, 48073, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Holy Name Hospital
Teaneck New Jersey, 07666, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Carolinas Hematology-Oncology Associates
Charlotte North Carolina, 28203, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Altru Health Systems
Grand Forks North Dakota, 58201, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
St. Mark's Hospital
Salt Lake City Utah, 84124, United States
University of Washington
Seattle Washington, 98109, United States
Aurora St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
Milwaukee Wisconsin, 53226, United States
Concord Hospital
Concord New South Wales, 2139, Australia
St. Vincent's Hospital
Darlinghurst New South Wales, 2010, Australia
Nepean Cancer Care Centre
Kingswood New South Wales, , Australia
St. George Hospital
Kogarah New South Wales, 2217, Australia
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Sydney Adventist Hospital
Wahroonga New South Wales, 2076, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Wesley Medical Centre
Auchenflower Queensland, 4066, Australia
Cairns Private Hospital
Cairns Queensland, 4870, Australia
Royal Brisbane and Women's Hospital
Herston Queensland, 4029, Australia
Gold Coast Health Service District
Southport Queensland, 4215, Australia
HOCA Gold Coast Centre
Southport Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, , Australia
Royal Adelaide Hospital
Adelaide South Australia, , Australia
Ashford Cancer Centre
Ashford South Australia, , Australia
Flinders Medical Centre
Bedford Park South Australia, , Australia
Lyell McEwin Hospital
Elizabeth Vale South Australia, 5012, Australia
Queen Elizabeth II Hospital
Woodville South South Australia, , Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Monash Medical Centre
Bentleigh East Victoria, , Australia
John Fawkner Private Hospital
Coburg Victoria, 3058, Australia
Western Hospital
Footscray Victoria, 3011, Australia
Peninsula Oncology Centre
Frankston Victoria, 3199, Australia
South Eastern Private
Noble Park Victoria, 3174, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Maroondah Public
Ringwood East Victoria, 3135, Australia
Ringwood/Knox Private
Ringwood Victoria, 3135, Australia
Hollywood Private Hospital
Nedlands Western Australia, 6009, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, , Australia
Mount Medical Centre
Perth Western Australia, 6005, Australia
Royal Perth Hospital
Perth Western Australia, , Australia
OL Vrouw Ziekenhuis Aalst Gastro-Enterologie
Aalst , 9300, Belgium
ZNA Middelheim
Antwerpen , 2020, Belgium
Antwerp University Hospital
Antwerp , , Belgium
Imelda Ziekenhuis GI Clinical Research Centre
Bonheiden , 2820, Belgium
Sint-Josef Ziekenhuie (Campus Bornem)
Bornem , 2880, Belgium
Institut Jules Bordet - Centre de Tumeurs d'ULB
Brussels , , Belgium
Universiteits Ziekenhuis Gent
Gent , 9000, Belgium
AZ Maria Middelares
Gent , , Belgium
Hospital de Jolimont
Haine-Saint-Paul , 7100, Belgium
UZ Leuven, Campus Gasthuisberg
Leuven , 3000, Belgium
Centre Hospitalier Universitaire de Liege
Liege , , Belgium
VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel
Mechelen , 2800, Belgium
AZ Heilige Familie
Reet , 2840, Belgium
Sint-Augustinus Ziekenhuis
Wilrijk , 2610, Belgium
CHU de Bordeau
Bordeaux , 33000, France
Hospitalier Universitaire de Grenoble C.H.U.
La Tronche , 38700, France
Centre Hospitalier General de Longjumeau
Longjumeau , 91161, France
Hopital de l'Archet II, CHU de Nice
Nice , 06202, France
Hospital European Georges Pompidou
Paris , 7590, France
Centre Eugene Marquis
Rennes Cedex , , France
Internistische Gemeinschaftspraxis
Altstadt , 84028, Germany
Charite Campus Virchow Klinikum
Berlin , 1335, Germany
Braxiskooperation Bonn, Fachartze fur Innere Medizin
Bonn , 53123, Germany
Johanniterkrankenhaus Bonn
Bonn , , Germany
Universitaetsklinikum Bonn
Bonn , , Germany
Kliniken Essen Mitte
Essen , 45136, Germany
Gemeinschaftspraxis Hamatologie und internistische Onkologie
Essen , , Germany
Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie
Frankfurt , 6059, Germany
Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin
Hamburg , 20367, Germany
Universitastsklinikum Saarland
Hamburg , , Germany
Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl
Holzkirch , 83607, Germany
Onklogische Praxis Dr. Gerald Gehbauer
Ingolstadt , 85049, Germany
Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik
Karlsruhe , 76133, Germany
Schwerpunktpraxis fur Hamatologie und Onkologie
Magdeburg , 39104, Germany
Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie
Magdeburg , 39130, Germany
Universitaetsklinikum Magdeburg
Magdeburg , , Germany
Universitatsklinikum GieBen und Marburg
Marburg , 35043, Germany
Klinikum Bogenhausen
Muenchen , , Germany
Klinikum der Universitaet Muenchen
Muenchen , , Germany
Hamato-Onkologische Schwerpunktspraxis
Munchen , , Germany
Klinikum rechts der Isar der TU Munchen
Munchen , , Germany
Schwerpunktspraxis fur Hamatologie und Internistische Onkologie
Munchen , , Germany
Praxis fur Hamatologie und Internnistische Onkologie
Velbert , 42551, Germany
Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr
Weilheim , , Germany
Rambam Medical Center
Haifa , , Israel
Shaare-Zedek Medical Centre
Jerusalem , 91031, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tiqva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
TA Sourasky Medical Center
Tel Aviv , 64239, Israel
A.O.U. die Bologna
Bologna , 40138, Italy
University of Auckland
Auckland , , New Zealand
Christchurch Hospital
Christchurch , , New Zealand
Dunedin Hospital
Dunedin , , New Zealand
Wellington Hospital
Newtown , , New Zealand
Palmerston North Hospital
Palmerston , , New Zealand
Wojskowy Instytut Medyczny (WIM)
Warsaw , 04-14, Poland
Clinica Universitaria de Navarra
Pamplona , 31008, Spain
Hospital de Navarra, Servicio de Ongoligia, Planta Baja
Pamplona , 31008, Spain
Universitatsspital Zurich
Zurich , CH-80, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

530

Study ID:

NCT00724503

Recruitment Status:

Completed

Sponsor:


Sirtex Medical

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider