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

Not Applicable

Completed

Conditions: Colorectal Cancer
Colorectal Carcinoma
Liver Metastases

Interventions: Device: SIR-Spheres yttrium-90 microspheres
Drug: Systemic chemotherapy (FOLFOX)

Registration Number: NCT00724503

Lead Sponsor: Sirtex Medical

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 530

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mFOLFOX6 + SIRT	SIR-Spheres yttrium-90 microspheres	A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
mFOLFOX6	Systemic chemotherapy (FOLFOX)	Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) at Any Site	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Overall Response	Through study completion, up to 60 months	Tumour Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR) - Disappearance of all target lesions which is confirmed if determined by two observations not less than 4 weeks apart; Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Trial Locations

Locations (111): Ringwood/Knox Private
🇦🇺
Ringwood, Victoria, Australia
VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel
🇧🇪
Mechelen, Belgium
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Holy Name Hospital
🇺🇸
Teaneck, New Jersey, United States
Nepean Cancer Care Centre
🇦🇺
Kingswood, New South Wales, Australia
City of Hope Hospital
🇺🇸
Duarte, California, United States
Concord Hospital
🇦🇺
Concord, New South Wales, Australia
OL Vrouw Ziekenhuis Aalst Gastro-Enterologie
🇧🇪
Aalst, Belgium
Princess Alexandra Hospital
🇦🇺
Woolloongabba, Queensland, Australia
Sint-Augustinus Ziekenhuis
🇧🇪
Wilrijk, Belgium
Ashford Cancer Centre
🇦🇺
Ashford, South Australia, Australia
Western Hospital
🇦🇺
Footscray, Victoria, Australia
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
🇺🇸
Milwaukee, Wisconsin, United States
Monash Medical Centre
🇦🇺
Bentleigh East, Victoria, Australia
Adventist Hinsdale Hospital
🇺🇸
Hinsdale, Illinois, United States
Imelda Ziekenhuis GI Clinical Research Centre
🇧🇪
Bonheiden, Belgium
CHU de Bordeau
🇫🇷
Bordeaux, France
Aurora St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
St. Vincent's Hospital
🇦🇺
Darlinghurst, New South Wales, Australia
Flinders Medical Centre
🇦🇺
Bedford Park, South Australia, Australia
Antwerp University Hospital
🇧🇪
Antwerp, Belgium
Institut Jules Bordet - Centre de Tumeurs d'ULB
🇧🇪
Brussels, Belgium
Royal Melbourne Hospital
🇦🇺
Parkville, Victoria, Australia
South Eastern Private
🇦🇺
Noble Park, Victoria, Australia
Clinica Universitaria de Navarra
🇪🇸
Pamplona, Spain
AZ Heilige Familie
🇧🇪
Reet, Belgium
Wojskowy Instytut Medyczny (WIM)
🇵🇱
Warsaw, Poland
Gold Coast Health Service District
🇦🇺
Southport, Queensland, Australia
John Fawkner Private Hospital
🇦🇺
Coburg, Victoria, Australia
Schwerpunktpraxis fur Hamatologie und Onkologie
🇩🇪
Magdeburg, Germany
Universitaetsklinikum Bonn
🇩🇪
Bonn, Germany
Dunedin Hospital
🇳🇿
Dunedin, New Zealand
Praxis fur Hamatologie und Internnistische Onkologie
🇩🇪
Velbert, Germany
Shaare-Zedek Medical Centre
🇮🇱
Jerusalem, Israel
Universiteits Ziekenhuis Gent
🇧🇪
Gent, Belgium
Sir Charles Gairdner Hospital
🇦🇺
Nedlands, Western Australia, Australia
Charite Campus Virchow Klinikum
🇩🇪
Berlin, Germany
Centre Hospitalier General de Longjumeau
🇫🇷
Longjumeau, France
Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin
🇩🇪
Hamburg, Germany
Hospital de Jolimont
🇧🇪
Haine-Saint-Paul, Belgium
Hopital de l'Archet II, CHU de Nice
🇫🇷
Nice, France
Braxiskooperation Bonn, Fachartze fur Innere Medizin
🇩🇪
Bonn, Germany
Kliniken Essen Mitte
🇩🇪
Essen, Germany
Rambam Medical Center
🇮🇱
Haifa, Israel
Wellington Hospital
🇳🇿
Newtown, New Zealand
Palmerston North Hospital
🇳🇿
Palmerston, New Zealand
Hospital European Georges Pompidou
🇫🇷
Paris, France
TA Sourasky Medical Center
🇮🇱
Tel Aviv, Israel
A.O.U. die Bologna
🇮🇹
Bologna, Italy
Universitastsklinikum Saarland
🇩🇪
Hamburg, Germany
Klinikum rechts der Isar der TU Munchen
🇩🇪
Munchen, Germany
Johanniterkrankenhaus Bonn
🇩🇪
Bonn, Germany
Universitatsspital Zurich
🇨🇭
Zurich, Switzerland
Hospital de Navarra, Servicio de Ongoligia, Planta Baja
🇪🇸
Pamplona, Spain
Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl
🇩🇪
Holzkirch, Germany
Rabin Medical Center, Beilinson Hospital
🇮🇱
Petah Tiqva, Israel
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Altru Health Systems
🇺🇸
Grand Forks, North Dakota, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Washington
🇺🇸
Seattle, Washington, United States
Royal Brisbane and Women's Hospital
🇦🇺
Herston, Queensland, Australia
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Virginia Piper Cancer Institute
🇺🇸
Minneapolis, Minnesota, United States
Mount Medical Centre
🇦🇺
Perth, Western Australia, Australia
Royal Perth Hospital
🇦🇺
Perth, Western Australia, Australia
St. Mark's Hospital
🇺🇸
Salt Lake City, Utah, United States
Centre Eugene Marquis
🇫🇷
Rennes Cedex, France
Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie
🇩🇪
Frankfurt, Germany
Onklogische Praxis Dr. Gerald Gehbauer
🇩🇪
Ingolstadt, Germany
Universitaetsklinikum Magdeburg
🇩🇪
Magdeburg, Germany
Klinikum Bogenhausen
🇩🇪
Muenchen, Germany
Hamato-Onkologische Schwerpunktspraxis
🇩🇪
Munchen, Germany
HOCA Gold Coast Centre
🇦🇺
Southport, Queensland, Australia
St. George Hospital
🇦🇺
Kogarah, New South Wales, Australia
Pinnacle Oncology Hematology
🇺🇸
Scottsdale, Arizona, United States
Florida International University College of Medicine Practice
🇺🇸
North Miami Beach, Florida, United States
Vanguard Health
🇺🇸
Berwyn, Illinois, United States
University of Maryland Medical Center
🇺🇸
Baltimore, Maryland, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Wesley Medical Centre
🇦🇺
Auchenflower, Queensland, Australia
Sydney Adventist Hospital
🇦🇺
Wahroonga, New South Wales, Australia
Lyell McEwin Hospital
🇦🇺
Elizabeth Vale, South Australia, Australia
Queen Elizabeth II Hospital
🇦🇺
Woodville South, South Australia, Australia
Royal Hobart Hospital
🇦🇺
Hobart, Tasmania, Australia
Peninsula Oncology Centre
🇦🇺
Frankston, Victoria, Australia
ZNA Middelheim
🇧🇪
Antwerpen, Belgium
AZ Maria Middelares
🇧🇪
Gent, Belgium
Sint-Josef Ziekenhuie (Campus Bornem)
🇧🇪
Bornem, Belgium
Centre Hospitalier Universitaire de Liege
🇧🇪
Liege, Belgium
UZ Leuven, Campus Gasthuisberg
🇧🇪
Leuven, Belgium
Hospitalier Universitaire de Grenoble C.H.U.
🇫🇷
La Tronche, France
Internistische Gemeinschaftspraxis
🇩🇪
Altstadt, Germany
Gemeinschaftspraxis Hamatologie und internistische Onkologie
🇩🇪
Essen, Germany
Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik
🇩🇪
Karlsruhe, Germany
Universitatsklinikum GieBen und Marburg
🇩🇪
Marburg, Germany
Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie
🇩🇪
Magdeburg, Germany
Schwerpunktspraxis fur Hamatologie und Internistische Onkologie
🇩🇪
Munchen, Germany
Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr
🇩🇪
Weilheim, Germany
Klinikum der Universitaet Muenchen
🇩🇪
Muenchen, Germany
Sheba Medical Center
🇮🇱
Ramat Gan, Israel
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
University of Auckland
🇳🇿
Auckland, New Zealand
University of Illinois at Chicago
🇺🇸
Chicago, Illinois, United States
Ingalls Memorial Hospital
🇺🇸
Harvey, Illinois, United States
Carolinas Hematology-Oncology Associates
🇺🇸
Charlotte, North Carolina, United States
Royal North Shore Hospital
🇦🇺
St Leonards, New South Wales, Australia
Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia
Hollywood Private Hospital
🇦🇺
Nedlands, Western Australia, Australia
Cairns Private Hospital
🇦🇺
Cairns, Queensland, Australia
Maroondah Public
🇦🇺
Ringwood East, Victoria, Australia
Montefiore Medical Center
🇺🇸
Bronx, New York, United States