FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer (SIRFLOX)
This study is ongoing, but not recruiting participants.
Sponsor:
Sirtex Medical
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT00724503
First received: July 25, 2008
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
This study is a randomized multi-center trial that will assess the effect of adding 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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer Colorectal Carcinoma Liver Metastases |
Drug: Systemic chemotherapy (FOLFOX) Device: SIR-Spheres yttrium-90 microspheres |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma |
Resource links provided by NLM:
Further study details as provided by Sirtex Medical:
Primary Outcome Measures:
- progression free survival [ Time Frame: from randomisation until progressive disease is confirmed or upon patient death if disease progression has not been evident at that time ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 518 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | April 2018 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A: FOLFOX alone
Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)
|
Drug: Systemic chemotherapy (FOLFOX)
Oxaliplatin 85 mg/m2, IV infusion, q two weeks Leucovorin 200 mg/m2, IV infusion, q two weeks 5-Fluorouracil 400 mg/m2, IV bolus, q two weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks Other Name: FOLFOX6m
|
|
Active Comparator: B: FOLFOX + SIR-Spheres
A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
|
Device: SIR-Spheres yttrium-90 microspheres
SIR-Spheres microspheres implanted once on the 3rd or 4th day of the first week of the first chemotherapy cycle
Other Names:
Drug: Systemic chemotherapy (FOLFOX)
Oxaliplatin 60 mg/m2,IV infusion, q two weeks for first 3 cycles Oxaliplatin 85 mg/m2, IV infusion, q two weeks from cycle 4 onwards Leucovorin 200 mg/m2, IV infusion, q two weeks 5-Fluorouracil 400 mg/m2, IV bolus, q two weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks Other Name: FOLFOX6m
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724503
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Hide Study LocationsLocations
| United States, Arizona | |
| Arizona Center for Cancer Care | |
| Glendale, Arizona, United States, 85306 | |
| Pinnacle Oncology Hematology | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| City of Hope Hospital | |
| Duarte, California, United States, 91010 | |
| United States, Florida | |
| Florida International University College of Medicine Practice | |
| North Miami Beach, Florida, United States, 33169 | |
| United States, Illinois | |
| Vanguard Health | |
| Berwyn, Illinois, United States, 60402 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 80426 | |
| Adventist Hinsdale Hospital | |
| Hinsdale, Illinois, United States, 60525 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Greenbaum Cancer Center | |
| Glen Burnie, Maryland, United States, 21061 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Virginia Piper Cancer Institute | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New Jersey | |
| Holy Name Hospital | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Levine Cancer Institute | |
| Charlotte, North Carolina, United States, 28211 | |
| Carolinas Hematology-Oncology Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| Carolinas Hematology-Oncology Associates - Ballantyne | |
| Charlotte, North Carolina, United States, 28277 | |
| Carolinas Hematology-Oncology - Ballantyne | |
| Charlotte, North Carolina, United States, 28277 | |
| Mecklenburg Medical Group - Morehead | |
| Charlotte, North Carolina, United States, 28204 | |
| Mecklenburg Medical Group - Pineville | |
| Charlotte, North Carolina, United States, 28210 | |
| Mecklenburg Medical Group - South Park | |
| Charlotte, North Carolina, United States, 28211 | |
| Mecklenburg Medical Group | |
| Charlotte, North Carolina, United States, 28204 | |
| Levine Cancer Institute - Blumenthal Cancer Center | |
| Charlotte, North Carolina, United States, 28204 | |
| Carolinas Hematology-Oncology Associates - University | |
| Charlotte, North Carolina, United States, 28262 | |
| Northeast Oncology Associates | |
| Concord, North Carolina, United States, 28025 | |
| Mecklenburg Medical Group - Carolinas Cancer Associates | |
| Monroe, North Carolina, United States, 28112 | |
| United States, North Dakota | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Pennsylvania | |
| UPMC Cancer Center Beaver | |
| Beaver, Pennsylvania, United States, 15009 | |
| UPMC Cancer Center Arnold Palmer at Mountain View | |
| Greensburg, Pennsylvania, United States, 15601 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| UPMC Cancer Center Passavant | |
| Pittsburgh, Pennsylvania, United States, 15237 | |
| UPMC Hillman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| UPMC Cancer Center Uniontown | |
| Uniontown, Pennsylvania, United States, 15401 | |
| United States, Utah | |
| Utah Cancer Specialists - Bountiful/Lakeview Office | |
| Bountiful, Utah, United States, 84010 | |
| Utah Cancer Specialists - Layton/Davis Office | |
| Layton, Utah, United States, 84041 | |
| Utah Cancer Specialists - Cottonwood Office | |
| Murray, Utah, United States, 84157 | |
| Utah Cancer Specialists - Provo Office | |
| Provo, Utah, United States, 84604 | |
| Utah Cancer Specialists - Salt Lake Regional | |
| Salt Lake City, Utah, United States, 84102 | |
| Utah Cancer Specialists | |
| Salt Lake City, Utah, United States, 84106 | |
| St. Mark's Hospital | |
| Salt Lake City, Utah, United States, 84124 | |
| Utah Cancer Specialists - Salt Lake Clinic | |
| Salt Lake City, Utah, United States, 84102 | |
| Utah Cancer Specialists - Jordan Valley | |
| West Jordan, Utah, United States, 84088 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98109 | |
| United States, Wisconsin | |
| Aurora St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, New South Wales | |
| Concord Hospital | |
| Concord, New South Wales, Australia, 2139 | |
| St. Vincent's Hospital | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Nepean Cancer Care Centre | |
| Kingswood, New South Wales, Australia | |
| St. George Hospital | |
| Kogarah, New South Wales, Australia, 2217 | |
| Royal North Shore Hospital | |
| St Leonards, New South Wales, Australia, 2065 | |
| Sydney Adventist Hospital | |
| Wahroonga, New South Wales, Australia, 2076 | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Wesley Medical Centre | |
| Auchenflower, Queensland, Australia, 4066 | |
| Cairns Private Hospital | |
| Cairns, Queensland, Australia, 4870 | |
| Royal Brisbane and Women's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| HOCA Gold Coast Centre | |
| Southport, Queensland, Australia, 4215 | |
| Gold Coast Health Service District | |
| Southport, Queensland, Australia, 4215 | |
| Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia | |
| Flinders Medical Centre | |
| Bedford Park, South Australia, Australia | |
| Lyell McEwin Hospital | |
| Elizabeth Vale, South Australia, Australia, 5012 | |
| Queen Elizabeth II Hospital | |
| Woodville South, South Australia, Australia | |
| Australia, Tasmania | |
| Royal Hobart Hospital | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| John Fawkner Private Hospital | |
| Coburg, Victoria, Australia, 3058 | |
| Monash Medical Centre | |
| East Bentleigh, Victoria, Australia | |
| Western Hospital | |
| Footscray, Victoria, Australia, 3011 | |
| Peninsula Oncology Centre | |
| Frankston, Victoria, Australia, 3199 | |
| South Eastern Private | |
| Noble Park, Victoria, Australia, 3174 | |
| Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Ringwood/Knox Private | |
| Ringwood, Victoria, Australia, 3135 | |
| Maroondah Public | |
| Ringwood East, Victoria, Australia, 3135 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia | |
| Hollywood Private Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Mount Medical Centre | |
| Perth, Western Australia, Australia, 6005 | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia | |
| Belgium | |
| OL Vrouw Ziekenhuis Aalst Gastro-Enterologie | |
| Aalst, Belgium, 9300 | |
| Antwerp University Hospital | |
| Antwerp, Belgium | |
| ZNA Middelheim | |
| Antwerpen, Belgium, 2020 | |
| Imelda Ziekenhuis GI Clinical Research Centre | |
| Bonheiden, Belgium, 2820 | |
| Sint-Josef Ziekenhuie (Campus Bornem) | |
| Bornem, Belgium, 2880 | |
| Institut Jules Bordet - Centre de Tumeurs d'ULB | |
| Brussels, Belgium | |
| Universiteits Ziekenhuis Gent | |
| Gent, Belgium, 9000 | |
| AZ Maria Middelares | |
| Gent, Belgium | |
| Hospital de Jolimont | |
| Haine-Saint-Paul, Belgium, 7100 | |
| UZ Leuven, Campus Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Centre Hospitalier Universitaire de Liege | |
| Liege, Belgium | |
| VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel | |
| Mechelen, Belgium, 2800 | |
| AZ Heilige Familie | |
| Reet, Belgium, 2840 | |
| Sint-Augustinus Ziekenhuis | |
| Wilrijk, Belgium, 2610 | |
| France | |
| CHU de Bordeau | |
| Bordeaux, France, 33000 | |
| Hospitalier Universitaire de Grenoble C.H.U. | |
| La Tronche, France, 38700 | |
| Centre Hospitalier General de Longjumeau | |
| Longjumeau, France, 91161 | |
| Hopital de l'Archet II, CHU de Nice | |
| Nice, France, 06202 | |
| Hospital European Georges Pompidou | |
| Paris, France, 7590 | |
| Centre Eugene Marquis | |
| Rennes Cedex, France | |
| Germany | |
| Internistische Gemeinschaftspraxis | |
| Altstadt, Germany, 84028 | |
| Charite Campus Virchow Klinikum | |
| Berlin, Germany, 1335 | |
| Universitaetsklinikum Bonn | |
| Bonn, Germany | |
| Johanniterkrankenhaus Bonn | |
| Bonn, Germany | |
| Braxiskooperation Bonn, Fachartze fur Innere Medizin | |
| Bonn, Germany, 53123 | |
| Kliniken Essen Mitte | |
| Essen, Germany, 45136 | |
| Gemeinschaftspraxis Hamatologie und internistische Onkologie | |
| Essen, Germany | |
| Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie | |
| Frankfurt, Germany, 6059 | |
| Universitastsklinikum Saarland | |
| Hamburg, Germany | |
| Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin | |
| Hamburg, Germany, 20367 | |
| Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl | |
| Holzkirch, Germany, 83607 | |
| Onklogische Praxis Dr. Gerald Gehbauer | |
| Ingolstadt, Germany, 85049 | |
| Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik | |
| Karlsruhe, Germany, 76133 | |
| Universitaetsklinikum Magdeburg | |
| Magdeburg, Germany | |
| Schwerpunktpraxis fur Hamatologie und Onkologie | |
| Magdeburg, Germany, 39104 | |
| Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie | |
| Magdeburg, Germany, 39130 | |
| Universitatsklinikum GieBen und Marburg | |
| Marburg, Germany, 35043 | |
| Klinikum der Universitaet Muenchen | |
| Muenchen, Germany | |
| Klinikum Bogenhausen | |
| Muenchen, Germany | |
| Hamato-Onkologische Schwerpunktspraxis | |
| Munchen, Germany | |
| Schwerpunktspraxis fur Hamatologie und Internistische Onkologie | |
| Munchen, Germany | |
| Klinikum rechts der Isar der TU Munchen | |
| Munchen, Germany | |
| Praxis fur Hamatologie und Internnistische Onkologie | |
| Velbert, Germany, 42551 | |
| Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr | |
| Weilheim, Germany | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel | |
| Shaare-Zedek Medical Centre | |
| Jerusalem, Israel, 91031 | |
| Rabin Medical Center, Beilinson Hospital | |
| Petah Tiqva, Israel, 49100 | |
| Sheba Medical Center | |
| Ramat Gan, Israel, 52621 | |
| TA Sourasky Medical Center | |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| A.O.U. die Bologna | |
| Bologna, Italy, 40138 | |
| New Zealand | |
| 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 | |
| Poland | |
| Wojskowy Instytut Medyczny (WIM) | |
| Warsaw, Poland, 04-141 | |
| Spain | |
| Clinica Universitaria de Navarra | |
| Pamplona, Spain, 31008 | |
| Hospital de Navarra, Servicio de Ongoligia, Planta Baja | |
| Pamplona, Spain, 31008 | |
| Switzerland | |
| Universitatsspital Zurich | |
| Zurich, Switzerland, CH-8091 | |
Sponsors and Collaborators
Sirtex Medical
Investigators
| Principal Investigator: | Peter Gibbs, MD | Melbourne Health |
| Principal Investigator: | Guy van Hazel, MD | Mount Medical Centre |
More Information
No publications provided
| Responsible Party: | Sirtex Medical |
| ClinicalTrials.gov Identifier: | NCT00724503 History of Changes |
| Other Study ID Numbers: | STX0206 |
| Study First Received: | July 25, 2008 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Human Research Ethics Committee Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Sirtex Medical:
|
colon cancer Colorectal carcinoma liver metastases SIR-Spheres microspheres |
yttrium-90 FOLFOX bevacizumab metastatic colorectal cancer |
Additional relevant MeSH terms:
|
Carcinoma Colorectal Neoplasms Neoplasm Metastasis Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Neoplastic Processes Pathologic Processes Liver Diseases Fluorouracil Oxaliplatin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013