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

Primary Purpose

Colorectal Cancer, Colorectal Carcinoma, Liver Metastases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SIR-Spheres yttrium-90 microspheres
Systemic chemotherapy (FOLFOX)
Sponsored by
Sirtex Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colon cancer, Colorectal carcinoma, liver metastases, SIR-Spheres microspheres, yttrium-90, FOLFOX, bevacizumab, metastatic colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pinnacle Oncology Hematology
  • City of Hope Hospital
  • Florida International University College of Medicine Practice
  • Vanguard Health
  • University of Illinois at Chicago
  • Ingalls Memorial Hospital
  • Adventist Hinsdale Hospital
  • University of Louisville
  • University of Maryland Medical Center
  • William Beaumont Hospital
  • Virginia Piper Cancer Institute
  • Holy Name Hospital
  • Montefiore Medical Center
  • Carolinas Hematology-Oncology Associates
  • Carolinas Medical Center
  • Altru Health Systems
  • University of Pittsburgh Medical Center
  • St. Mark's Hospital
  • University of Washington
  • Aurora St. Luke's Medical Center
  • Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
  • Concord Hospital
  • St. Vincent's Hospital
  • Nepean Cancer Care Centre
  • St. George Hospital
  • Royal North Shore Hospital
  • Sydney Adventist Hospital
  • Westmead Hospital
  • Wesley Medical Centre
  • Cairns Private Hospital
  • Royal Brisbane and Women's Hospital
  • Gold Coast Health Service District
  • HOCA Gold Coast Centre
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Ashford Cancer Centre
  • Flinders Medical Centre
  • Lyell McEwin Hospital
  • Queen Elizabeth II Hospital
  • Royal Hobart Hospital
  • Monash Medical Centre
  • John Fawkner Private Hospital
  • Western Hospital
  • Peninsula Oncology Centre
  • South Eastern Private
  • Royal Melbourne Hospital
  • Maroondah Public
  • Ringwood/Knox Private
  • Hollywood Private Hospital
  • Sir Charles Gairdner Hospital
  • Mount Medical Centre
  • Royal Perth Hospital
  • OL Vrouw Ziekenhuis Aalst Gastro-Enterologie
  • ZNA Middelheim
  • Antwerp University Hospital
  • Imelda Ziekenhuis GI Clinical Research Centre
  • Sint-Josef Ziekenhuie (Campus Bornem)
  • Institut Jules Bordet - Centre de Tumeurs d'ULB
  • Universiteits Ziekenhuis Gent
  • AZ Maria Middelares
  • Hospital de Jolimont
  • UZ Leuven, Campus Gasthuisberg
  • Centre Hospitalier Universitaire de Liege
  • VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel
  • AZ Heilige Familie
  • Sint-Augustinus Ziekenhuis
  • CHU de Bordeau
  • Hospitalier Universitaire de Grenoble C.H.U.
  • Centre Hospitalier General de Longjumeau
  • Hopital de l'Archet II, CHU de Nice
  • Hospital European Georges Pompidou
  • Centre Eugene Marquis
  • Internistische Gemeinschaftspraxis
  • Charite Campus Virchow Klinikum
  • Braxiskooperation Bonn, Fachartze fur Innere Medizin
  • Johanniterkrankenhaus Bonn
  • Universitaetsklinikum Bonn
  • Kliniken Essen Mitte
  • Gemeinschaftspraxis Hamatologie und internistische Onkologie
  • Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie
  • Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin
  • Universitastsklinikum Saarland
  • Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl
  • Onklogische Praxis Dr. Gerald Gehbauer
  • Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik
  • Schwerpunktpraxis fur Hamatologie und Onkologie
  • Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie
  • Universitaetsklinikum Magdeburg
  • Universitatsklinikum GieBen und Marburg
  • Klinikum Bogenhausen
  • Klinikum der Universitaet Muenchen
  • Hamato-Onkologische Schwerpunktspraxis
  • Klinikum rechts der Isar der TU Munchen
  • Schwerpunktspraxis fur Hamatologie und Internistische Onkologie
  • Praxis fur Hamatologie und Internnistische Onkologie
  • Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr
  • Rambam Medical Center
  • Shaare-Zedek Medical Centre
  • Rabin Medical Center, Beilinson Hospital
  • Sheba Medical Center
  • TA Sourasky Medical Center
  • A.O.U. die Bologna
  • University of Auckland
  • Christchurch Hospital
  • Dunedin Hospital
  • Wellington Hospital
  • Palmerston North Hospital
  • Wojskowy Instytut Medyczny (WIM)
  • Clinica Universitaria de Navarra
  • Hospital de Navarra, Servicio de Ongoligia, Planta Baja
  • Universitatsspital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mFOLFOX6 + SIRT

mFOLFOX6

Arm Description

A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)

Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) at Any Site
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

Percentage of Participants With Overall Response
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.

Full Information

First Posted
July 25, 2008
Last Updated
March 1, 2019
Sponsor
Sirtex Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00724503
Brief Title
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
Acronym
SIRFLOX
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2006 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirtex Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Carcinoma, Liver Metastases
Keywords
colon cancer, Colorectal carcinoma, liver metastases, SIR-Spheres microspheres, yttrium-90, FOLFOX, bevacizumab, metastatic colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mFOLFOX6 + SIRT
Arm Type
Experimental
Arm Description
A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Arm Title
mFOLFOX6
Arm Type
Active Comparator
Arm Description
Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).
Intervention Type
Device
Intervention Name(s)
SIR-Spheres yttrium-90 microspheres
Other Intervention Name(s)
mFOLFOX6m + SIRT, SIR-Spheres Y-90 microspheres
Intervention Description
SIR-Spheres microspheres (yttrium-90 [Y-90] labelled resin microspheres), hepatic artery injection administered on Day 3 or 4 of cycle 1. mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion. Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator. In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2.
Intervention Type
Drug
Intervention Name(s)
Systemic chemotherapy (FOLFOX)
Other Intervention Name(s)
mFOLFOX6
Intervention Description
mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion. Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator. In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) at Any Site
Description
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.
Time Frame
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With Overall Response
Description
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.
Time Frame
Through study completion, up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gibbs, MD
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guy van Hazel, MD
Organizational Affiliation
Mount Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pinnacle Oncology Hematology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
City of Hope Hospital
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Florida International University College of Medicine Practice
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Vanguard Health
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
80426
Country
United States
Facility Name
Adventist Hinsdale Hospital
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Carolinas Hematology-Oncology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Altru Health Systems
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
St. Mark's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Nepean Cancer Care Centre
City
Kingswood
State/Province
New South Wales
Country
Australia
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Wesley Medical Centre
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Cairns Private Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Gold Coast Health Service District
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
HOCA Gold Coast Centre
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Ashford Cancer Centre
City
Ashford
State/Province
South Australia
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5012
Country
Australia
Facility Name
Queen Elizabeth II Hospital
City
Woodville South
State/Province
South Australia
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Monash Medical Centre
City
Bentleigh East
State/Province
Victoria
Country
Australia
Facility Name
John Fawkner Private Hospital
City
Coburg
State/Province
Victoria
ZIP/Postal Code
3058
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Peninsula Oncology Centre
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
South Eastern Private
City
Noble Park
State/Province
Victoria
ZIP/Postal Code
3174
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Maroondah Public
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Ringwood/Knox Private
City
Ringwood
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Hollywood Private Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Mount Medical Centre
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
OL Vrouw Ziekenhuis Aalst Gastro-Enterologie
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Antwerp University Hospital
City
Antwerp
Country
Belgium
Facility Name
Imelda Ziekenhuis GI Clinical Research Centre
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Sint-Josef Ziekenhuie (Campus Bornem)
City
Bornem
ZIP/Postal Code
2880
Country
Belgium
Facility Name
Institut Jules Bordet - Centre de Tumeurs d'ULB
City
Brussels
Country
Belgium
Facility Name
Universiteits Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
Country
Belgium
Facility Name
Hospital de Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven, Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege
City
Liege
Country
Belgium
Facility Name
VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
AZ Heilige Familie
City
Reet
ZIP/Postal Code
2840
Country
Belgium
Facility Name
Sint-Augustinus Ziekenhuis
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
CHU de Bordeau
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hospitalier Universitaire de Grenoble C.H.U.
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalier General de Longjumeau
City
Longjumeau
ZIP/Postal Code
91161
Country
France
Facility Name
Hopital de l'Archet II, CHU de Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hospital European Georges Pompidou
City
Paris
ZIP/Postal Code
7590
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes Cedex
Country
France
Facility Name
Internistische Gemeinschaftspraxis
City
Altstadt
ZIP/Postal Code
84028
Country
Germany
Facility Name
Charite Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
1335
Country
Germany
Facility Name
Braxiskooperation Bonn, Fachartze fur Innere Medizin
City
Bonn
ZIP/Postal Code
53123
Country
Germany
Facility Name
Johanniterkrankenhaus Bonn
City
Bonn
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Kliniken Essen Mitte
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Gemeinschaftspraxis Hamatologie und internistische Onkologie
City
Essen
Country
Germany
Facility Name
Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie
City
Frankfurt
ZIP/Postal Code
6059
Country
Germany
Facility Name
Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin
City
Hamburg
ZIP/Postal Code
20367
Country
Germany
Facility Name
Universitastsklinikum Saarland
City
Hamburg
Country
Germany
Facility Name
Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl
City
Holzkirch
ZIP/Postal Code
83607
Country
Germany
Facility Name
Onklogische Praxis Dr. Gerald Gehbauer
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Schwerpunktpraxis fur Hamatologie und Onkologie
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie
City
Magdeburg
ZIP/Postal Code
39130
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Universitatsklinikum GieBen und Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Klinikum Bogenhausen
City
Muenchen
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen
City
Muenchen
Country
Germany
Facility Name
Hamato-Onkologische Schwerpunktspraxis
City
Munchen
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Munchen
City
Munchen
Country
Germany
Facility Name
Schwerpunktspraxis fur Hamatologie und Internistische Onkologie
City
Munchen
Country
Germany
Facility Name
Praxis fur Hamatologie und Internnistische Onkologie
City
Velbert
ZIP/Postal Code
42551
Country
Germany
Facility Name
Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr
City
Weilheim
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Shaare-Zedek Medical Centre
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petah Tiqva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
TA Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
A.O.U. die Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
University of Auckland
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston
Country
New Zealand
Facility Name
Wojskowy Instytut Medyczny (WIM)
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de Navarra, Servicio de Ongoligia, Planta Baja
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26903575
Citation
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. Erratum In: J Clin Oncol. 2016 Nov 20;34(33):4059.
Results Reference
result
PubMed Identifier
31840815
Citation
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.
Results Reference
derived
PubMed Identifier
28781171
Citation
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.
Results Reference
derived
PubMed Identifier
28351831
Citation
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.
Results Reference
derived
PubMed Identifier
25487708
Citation
Gibbs P, Gebski V, Van Buskirk M, Thurston K, Cade DN, Van Hazel GA; SIRFLOX Study Group. Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study. BMC Cancer. 2014 Dec 1;14:897. doi: 10.1186/1471-2407-14-897.
Results Reference
derived

Learn more about this trial

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

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