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Colorectal Cancer MetastaticPhase 3FOXFIREGlobalNCT01721954

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

A Phase 3 study testing FOLFOX6m and SIR-Spheres microspheres in people with Colorectal Cancer Metastatic, run by Sirtex Medical at 83 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
FOLFOX6m and SIR-Spheres microspheres
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
83 sitesin 13 countries
Study dates
1 May 2013to 28 Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • WHO performance status 0-1
  • Adequate hematological, renal and hepatic function
  • Life expectancy of at least 3 months without any active treatment

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

83 sites in 13 countries.

83 sites in 13 countries

United States18 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Roswell Park Cancer Center

    Buffalo, New York, 14263

  • Fletcher Allen Health Care

    Burlington, Vermont, 05405

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Illinois Chicago

    Chicago, Illinois, 60607

  • Methodist Hospital Dallas

    Dallas, Texas, 75203

  • City of Hope

    Duarte, California, 91010

  • Adventist Midwest Health

    Hinsdale, Illinois, 60521

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Lenox Hill Hospital

    New York, New York, 10075

  • Orlando Health

    Orlando, Florida, 32806

  • Memorial Healthcare

    Pembroke Pines, Florida, 33028

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124

  • Spartanburg Regional Healthcare / Gibbs Cancer Center

    Spartanburg, South Carolina, 29303

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Australia17 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • Monash Medical Centre

    Bentleigh East, Victoria, 3165

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Western Hospital

    Footscray, Victoria, 3011

  • Peninsula Oncology Centre

    Frankston, Victoria, 3199

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Hobart Hospital

    Hobart, Tasmania, 7000

  • St. John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • South Eastern Hospital

    Noble Park, Victoria, 3174

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Maroondah Hospital

    Ringwood East, Victoria, 3135

  • Gold Coast Health Services District

    Southport, Queensland, 4215

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany10 sites

  • Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie

    Berlin, 12351

  • SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie

    Heilbronn, 74078

  • Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin

    Karlsruhe, 76133

  • Schwerpunktpraxix fur Hamatologie und Onkologie

    Magdeburg, 39104

  • Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin

    Magdeburg, 39120

  • Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie

    Magdeburg, 39130

  • Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie

    Marburg, 35043

  • Klinikum rechts der Isar der TU Munchen Medizinische Klinik II

    München, 81675

  • Klinikum der Universitat Munchen

    Munich, 81377

  • St. Franziskus Hospital Muenster

    Münster, 48145

Other trials in Germany

France8 sites

  • CHU Amiens

    Amiens, 80054

  • Centre Hospitalier General de Longjumeau

    Clichy, 92118

  • Hopital Beaujon

    Clichy, 92118

  • Hopital Albert Michallon - Grenoble

    Grenoble, 38043

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • CHU de Bordeaux - Hopital Saint Andre

    Pessac, 33604

  • CHU de Poitiers, Pole regional de cancerologie

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

Other trials in France

Belgium6 sites

  • OL Vrouw Ziekenhuis

    Aalst, 9300

  • Institut Jules Bordet

    Brussels, 1000

  • University of Antwerp

    Edegem, 2650

  • Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie

    Ghent, 1K12IE

  • AZ Maria Middelaress

    Ghent, 9000

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Shaare-Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 91120

  • TA Sourasky Medical Center, Oncology Department 6

    Tel Aviv, 64239

  • Sheba Medical Center - Governmental Hospital - Oncology Division

    Tel HaShomer, 56261

Other trials in Israel

Italy5 sites

  • Ospedale Regionale U. Parini

    Aosta, 11100

  • Dipartimento di Oncologia, Ospendali Riuniti di Bergamo

    Bergamo, 24127

  • A.O.U. die Bologna

    Bologna, 40138

  • Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo

    Cuneo, 12100

  • U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello

    Pisa, 56124

Other trials in Italy

New Zealand4 sites

  • Dunedin Hospital

    Dunedin, 9016

  • Auckland University

    Grafton, 1023

  • Wellington Hospital

    Newtown, Wellington Region, 6021

  • Regional Cancer Treatment Service

    Palmerston North, 4414

Other trials in New Zealand

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 110-744

  • Korea University Anam Hospital

    Seoul, 136-705

  • Seoul St. Mary's Hospital

    Seoul, 137-701

Other trials in South Korea

Spain3 sites

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

Other trials in Spain

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 10048

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Portugal1 site

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200-072

Other trials in Portugal

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

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

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.

Being tested
FOLFOX6m, SIR-Spheres microspheres
Keywords
colon, rectum, metastatic colorectal cancer, liver metastases
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOX6mDrug

  • SIR-Spheres microspheresDevice

Study groups in NCT01721954
Study groupRoleWhat they receive
Control ArmActive comparatorSystemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
Receives: Drug: FOLFOX6m
Experimental ArmExperimentalSystemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Receives: Drug: FOLFOX6m; Device: SIR-Spheres microspheres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months

Secondary outcomes (1)

  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2012 (estimated)
  2. Study start1 May 2013
  3. Primary completion23 Dec 2016
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01721954
Sponsor's protocol ID
STX0112
Acronym
FOXFIREGlobal
Status last verified
Oct 2019
First submitted
26 Oct 2012
Last updated
5 Nov 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 26903575

  • 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.

    PubMed 31840815

  • 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.

    PubMed 28781171

  • 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.

    PubMed 28351831

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLFOX6m and SIR-Spheres microspheres in people with Colorectal Cancer Metastatic, run by Sirtex Medical at 83 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Australia, Germany, France, Belgium and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01721954, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.

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