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FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)

Primary Purpose

Colorectal Cancer Metastatic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FOLFOX6m
SIR-Spheres microspheres
Sponsored by
Sirtex Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring colon, rectum, metastatic colorectal cancer, liver metastases

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older
  • 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:

  • Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
  • 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

Sites / Locations

  • City of Hope
  • Orlando Health
  • Memorial Healthcare
  • University of Illinois Chicago
  • Adventist Midwest Health
  • Ochsner Clinic Foundation
  • University of Maryland Medical Center
  • Montefiore Medical Center
  • Roswell Park Cancer Center
  • Lenox Hill Hospital
  • Carolinas Medical Center
  • University of Pittsburgh Medical Center
  • Spartanburg Regional Healthcare / Gibbs Cancer Center
  • Methodist Hospital Dallas
  • St. Mark's Hospital
  • Fletcher Allen Health Care
  • West Virginia University Healthcare
  • Aurora St. Luke's Medical Center
  • Border Medical Oncology Research Unit
  • Gosford Hospital
  • Southern Medical Day Care Centre
  • Royal Brisbane Hospital
  • Gold Coast Health Services District
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Hobart Hospital
  • Monash Medical Centre
  • Box Hill Hospital
  • Western Hospital
  • Peninsula Oncology Centre
  • South Eastern Hospital
  • Maroondah Hospital
  • St. John of God Murdoch Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • OL Vrouw Ziekenhuis
  • Institut Jules Bordet
  • University of Antwerp
  • Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie
  • AZ Maria Middelaress
  • CHU Sart Tilman
  • CHU Amiens
  • Centre Hospitalier General de Longjumeau
  • Hopital Beaujon
  • Hopital Albert Michallon - Grenoble
  • Hopital Europeen Georges Pompidou
  • CHU de Bordeaux - Hopital Saint Andre
  • CHU de Poitiers, Pole regional de cancerologie
  • Centre Eugene Marquis
  • Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie
  • SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie
  • Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin
  • Schwerpunktpraxix fur Hamatologie und Onkologie
  • Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin
  • Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie
  • Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie
  • St. Franziskus Hospital Muenster
  • Klinikum rechts der Isar der TU Munchen Medizinische Klinik II
  • Klinikum der Universitat Munchen
  • Rambam Medical Center
  • Shaare-Zedek Medical Center
  • Hadassah Medical Center
  • TA Sourasky Medical Center, Oncology Department 6
  • Sheba Medical Center - Governmental Hospital - Oncology Division
  • Ospedale Regionale U. Parini
  • Dipartimento di Oncologia, Ospendali Riuniti di Bergamo
  • A.O.U. die Bologna
  • Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo
  • U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello
  • Seoul National University Hospital
  • Korea University Anam Hospital
  • Seoul St. Mary's Hospital
  • Wellington Hospital
  • Dunedin Hospital
  • Auckland University
  • Regional Cancer Treatment Service
  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
  • National Cancer Centre Singapore
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Clinica Universidad de Navarra
  • Complejo Hospitalario de Navarra
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm

Experimental Arm

Arm Description

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS defined as the time interval between the date of randomization and the date of death from any cause.

Secondary Outcome Measures

Progression-free Survival
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.

Full Information

First Posted
October 26, 2012
Last Updated
October 23, 2019
Sponsor
Sirtex Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01721954
Brief Title
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
Acronym
FOXFIREGlobal
Official Title
Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
December 23, 2016 (Actual)
Study Completion Date
February 28, 2017 (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 study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
Keywords
colon, rectum, metastatic colorectal cancer, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Intervention Type
Drug
Intervention Name(s)
FOLFOX6m
Intervention Type
Device
Intervention Name(s)
SIR-Spheres microspheres
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS defined as the time interval between the date of randomization and the date of death from any cause.
Time Frame
From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
Secondary Outcome Measure Information:
Title
Progression-free Survival
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 3 years 8 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older 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: Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment 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
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Memorial Healthcare
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Adventist Midwest Health
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Spartanburg Regional Healthcare / Gibbs Cancer Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Methodist Hospital Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
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
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
West Virginia University Healthcare
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
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
Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Gold Coast Health Services District
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Monash Medical Centre
City
Bentleigh East
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
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 Hospital
City
Noble Park
State/Province
Victoria
ZIP/Postal Code
3174
Country
Australia
Facility Name
Maroondah Hospital
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
St. John of God Murdoch Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
OL Vrouw Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University of Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie
City
Gent
ZIP/Postal Code
1K12IE
Country
Belgium
Facility Name
AZ Maria Middelaress
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Amiens
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier General de Longjumeau
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital Beaujon
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital Albert Michallon - Grenoble
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU de Bordeaux - Hopital Saint Andre
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Poitiers, Pole regional de cancerologie
City
Poitiers cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes Cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Schwerpunktpraxix fur Hamatologie und Onkologie
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie
City
Magdeburg
ZIP/Postal Code
39130
Country
Germany
Facility Name
Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
St. Franziskus Hospital Muenster
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Munchen Medizinische Klinik II
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum der Universitat Munchen
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shaare-Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
TA Sourasky Medical Center, Oncology Department 6
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center - Governmental Hospital - Oncology Division
City
Tel Hashomer
ZIP/Postal Code
56261
Country
Israel
Facility Name
Ospedale Regionale U. Parini
City
Aosta
ZIP/Postal Code
11100
Country
Italy
Facility Name
Dipartimento di Oncologia, Ospendali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
A.O.U. die Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Auckland University
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Regional Cancer Treatment Service
City
Palmerston North
ZIP/Postal Code
4414
Country
New Zealand
Facility Name
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
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

Learn more about this trial

FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

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