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Colorectal CancerSIRFLOXNCT00724503

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

A study testing SIR-Spheres yttrium-90 microspheres and Systemic chemotherapy (FOLFOX) in people with Colorectal Cancer and Colorectal Carcinoma, run by Sirtex Medical at 111 sites in 11 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 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SIR-Spheres yttrium-90 microspheres and Systemic chemotherapy (FOLFOX)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
530 participants
Where
111 sitesin 11 countries
Study dates
Aug 2006to May 2015
Phase
Interventional
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

  • 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.
Show all 9Show fewer
  • Age 18 years or older.
  • Willing and able to provide written informed consent.
  • Life expectancy of at least 3 months without any active treatment.

Who cannot join

  • 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.

Trial locations and contacts

111 sites in 11 countries.

111 sites in 11 countries

Australia31 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Ashford Cancer Centre

    Ashford, South Australia

  • Wesley Medical Centre

    Auchenflower, Queensland, 4066

  • Flinders Medical Centre

    Bedford Park, South Australia

  • Monash Medical Centre

    Bentleigh East, Victoria

  • Cairns Private Hospital

    Cairns, Queensland, 4870

  • John Fawkner Private Hospital

    Coburg, Victoria, 3058

  • Concord Hospital

    Concord, New South Wales, 2139

  • St. Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5012

  • Western Hospital

    Footscray, Victoria, 3011

  • Peninsula Oncology Centre

    Frankston, Victoria, 3199

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Nepean Cancer Care Centre

    Kingswood, New South Wales

  • St. George Hospital

    Kogarah, New South Wales, 2217

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

  • South Eastern Private

    Noble Park, Victoria, 3174

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mount Medical Centre

    Perth, Western Australia, 6005

  • Royal Perth Hospital

    Perth, Western Australia

  • Ringwood/Knox Private

    Ringwood, Victoria, 3135

  • Maroondah Public

    Ringwood East, Victoria, 3135

  • Gold Coast Health Service District

    Southport, Queensland, 4215

  • HOCA Gold Coast Centre

    Southport, Queensland, 4215

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Queen Elizabeth II Hospital

    Woodville South, South Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

Other trials in Australia

Germany24 sites

  • Internistische Gemeinschaftspraxis

    Altstadt, 84028

  • Charite Campus Virchow Klinikum

    Berlin, 1335

  • Braxiskooperation Bonn, Fachartze fur Innere Medizin

    Bonn, 53123

  • Johanniterkrankenhaus Bonn

    Bonn

  • Universitaetsklinikum Bonn

    Bonn

  • Kliniken Essen Mitte

    Essen, 45136

  • Gemeinschaftspraxis Hamatologie und internistische Onkologie

    Essen

  • Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie

    Frankfurt, 6059

  • Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin

    Hamburg, 20367

  • Universitastsklinikum Saarland

    Hamburg

  • Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl

    Holzkirch, 83607

  • Onklogische Praxis Dr. Gerald Gehbauer

    Ingolstadt, 85049

  • Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik

    Karlsruhe, 76133

  • Schwerpunktpraxis fur Hamatologie und Onkologie

    Magdeburg, 39104

  • Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie

    Magdeburg, 39130

  • Universitaetsklinikum Magdeburg

    Magdeburg

  • Universitatsklinikum GieBen und Marburg

    Marburg, 35043

  • Hamato-Onkologische Schwerpunktspraxis

    München

  • Klinikum Bogenhausen

    München

  • Klinikum der Universitaet Muenchen

    München

  • Klinikum rechts der Isar der TU Munchen

    München

  • Schwerpunktspraxis fur Hamatologie und Internistische Onkologie

    München

  • Praxis fur Hamatologie und Internnistische Onkologie

    Velbert, 42551

  • Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr

    Weilheim

Other trials in Germany

United States21 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Vanguard Health

    Berwyn, Illinois, 60402

  • Carolinas Hematology-Oncology Associates

    Charlotte, North Carolina, 28203

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • City of Hope Hospital

    Duarte, California, 91010

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • Ingalls Memorial Hospital

    Harvey, Illinois, 80426

  • Adventist Hinsdale Hospital

    Hinsdale, Illinois, 60525

  • University of Louisville

    Louisville, Kentucky, 40202

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Florida International University College of Medicine Practice

    North Miami Beach, Florida, 33169

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • University of Washington

    Seattle, Washington, 98109

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Belgium14 sites

  • OL Vrouw Ziekenhuis Aalst Gastro-Enterologie

    Aalst, 9300

  • ZNA Middelheim

    Antwerp, 2020

  • Antwerp University Hospital

    Antwerp

  • Imelda Ziekenhuis GI Clinical Research Centre

    Bonheiden, 2820

  • Sint-Josef Ziekenhuie (Campus Bornem)

    Bornem, 2880

  • Institut Jules Bordet - Centre de Tumeurs d'ULB

    Brussels

  • Universiteits Ziekenhuis Gent

    Ghent, 9000

  • AZ Maria Middelares

    Ghent

  • Hospital de Jolimont

    Haine-Saint-Paul, 7100

  • UZ Leuven, Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege

    Liège

  • VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel

    Mechelen, 2800

  • AZ Heilige Familie

    Reet, 2840

  • Sint-Augustinus Ziekenhuis

    Wilrijk, 2610

Other trials in Belgium

France6 sites

  • CHU de Bordeau

    Bordeaux, 33000

  • Hospitalier Universitaire de Grenoble C.H.U.

    La Tronche, 38700

  • Centre Hospitalier General de Longjumeau

    Longjumeau, 91161

  • Hopital de l'Archet II, CHU de Nice

    Nice, 06202

  • Hospital European Georges Pompidou

    Paris, 7590

  • Centre Eugene Marquis

    Rennes

Other trials in France

Israel5 sites

  • Rambam Medical Center

    Haifa

  • Shaare-Zedek Medical Centre

    Jerusalem, 91031

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • TA Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

New Zealand5 sites

  • University of Auckland

    Auckland

  • Christchurch Hospital

    Christchurch

  • Dunedin Hospital

    Dunedin

  • Wellington Hospital

    Newtown

  • Palmerston North Hospital

    Palmerston

Other trials in New Zealand

Spain2 sites

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital de Navarra, Servicio de Ongoligia, Planta Baja

    Pamplona, 31008

Other trials in Spain

Italy1 site

  • A.O.U. die Bologna

    Bologna, 40138

Other trials in Italy

Poland1 site

  • Wojskowy Instytut Medyczny (WIM)

    Warsaw, 04-141

Other trials in Poland

Switzerland1 site

  • Universitatsspital Zurich

    Zurich, CH-8091

Other trials in Switzerland

About this study

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

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.

Being tested
SIR-Spheres yttrium-90 microspheres, Systemic chemotherapy (FOLFOX)
Keywords
colon cancer, Colorectal carcinoma, liver metastases, SIR-Spheres microspheres, yttrium-90, FOLFOX, bevacizumab, metastatic colorectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

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

  • SIR-Spheres yttrium-90 microspheresDevice

    Also called mFOLFOX6m + SIRT, SIR-Spheres Y-90 microspheres

    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.

  • Systemic chemotherapy (FOLFOX)Drug

    Also called mFOLFOX6

    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.

Study groups in NCT00724503
Study groupRoleWhat they receive
mFOLFOX6 + SIRTExperimentalA single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Receives: Device: SIR-Spheres yttrium-90 microspheres
mFOLFOX6Active comparatorSystemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).
Receives: Drug: Systemic chemotherapy (FOLFOX)

What is being measured

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

  1. 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.

    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 60 months

Secondary outcomes (1)

  1. 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.

    Measured: Through study completion, up to 60 months

Timeline

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

  1. First posted29 Jul 2008 (estimated)
  2. Study startAug 2006
  3. Primary completionMay 2015
  4. Study completionMay 2015

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00724503
Sponsor's protocol ID
STX0206
Acronym
SIRFLOX
Status last verified
Mar 2019
First submitted
25 Jul 2008
Last updated
26 Mar 2019
Data monitoring committee
Yes

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

  • 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.

    PubMed 25487708

Questions about this trial

What is this clinical trial studying?

A study testing SIR-Spheres yttrium-90 microspheres and Systemic chemotherapy (FOLFOX) in people with Colorectal Cancer and Colorectal Carcinoma, run by Sirtex Medical at 111 sites in 11 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 8 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in Australia, Germany, United States, Belgium, France and 6 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 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?

Progression-Free Survival (PFS) at Any Site (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). 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 NCT00724503, which also lists 5 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 26 Mar 2019.

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