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

Colorectal Cancer Metastatic Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721954
• Other study ID #: STX0112
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2013
• Est. completion date: February 28, 2017

Study information

• Verified date: October 2019
• Source: Sirtex Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: February 28, 2017
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• FOLFOX6m

Device:
• SIR-Spheres microspheres

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Border Medical Oncology Research Unit	Albury	New South Wales
Australia	Monash Medical Centre	Bentleigh East	Victoria
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Western Hospital	Footscray	Victoria
Australia	Peninsula Oncology Centre	Frankston	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Hobart Hospital	Hobart	Tasmania
Australia	St. John of God Murdoch Hospital	Murdoch	Western Australia
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	South Eastern Hospital	Noble Park	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Maroondah Hospital	Ringwood East	Victoria
Australia	Gold Coast Health Services District	Southport	Queensland
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	OL Vrouw Ziekenhuis	Aalst
Belgium	Institut Jules Bordet	Brussels
Belgium	University of Antwerp	Edegem
Belgium	AZ Maria Middelaress	Gent
Belgium	Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie	Gent
Belgium	CHU Sart Tilman	Liege
France	CHU Amiens	Amiens Cedex 1
France	Centre Hospitalier General de Longjumeau	Clichy Cedex
France	Hopital Beaujon	Clichy Cedex
France	Hopital Albert Michallon - Grenoble	Grenoble Cedex 9
France	Hopital Europeen Georges Pompidou	Paris
France	CHU de Bordeaux - Hopital Saint Andre	Pessac
France	CHU de Poitiers, Pole regional de cancerologie	Poitiers cedex
France	Centre Eugene Marquis	Rennes Cedex
Germany	Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie	Berlin
Germany	SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie	Heilbronn
Germany	Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin	Karlsruhe
Germany	Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie	Magdeburg
Germany	Schwerpunktpraxix fur Hamatologie und Onkologie	Magdeburg
Germany	Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin	Magdeburg
Germany	Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie	Marburg
Germany	St. Franziskus Hospital Muenster	Muenster
Germany	Klinikum rechts der Isar der TU Munchen Medizinische Klinik II	Munchen
Germany	Klinikum der Universitat Munchen	Munich
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare-Zedek Medical Center	Jerusalem
Israel	TA Sourasky Medical Center, Oncology Department 6	Tel Aviv
Israel	Sheba Medical Center - Governmental Hospital - Oncology Division	Tel Hashomer
Italy	Ospedale Regionale U. Parini	Aosta
Italy	Dipartimento di Oncologia, Ospendali Riuniti di Bergamo	Bergamo
Italy	A.O.U. die Bologna	Bologna
Italy	Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo	Cuneo
Italy	U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello	Pisa
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Auckland University	Grafton
New Zealand	Wellington Hospital	Newtown	Wellington
New Zealand	Regional Cancer Treatment Service	Palmerston North
Portugal	Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.	Porto
Singapore	National Cancer Centre Singapore	Singapore
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Complejo Hospitalario de Navarra	Pamplona
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Roswell Park Cancer Center	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Illinois Chicago	Chicago	Illinois
United States	Methodist Hospital Dallas	Dallas	Texas
United States	City of Hope	Duarte	California
United States	Adventist Midwest Health	Hinsdale	Illinois
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	West Virginia University Healthcare	Morgantown	West Virginia
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	Orlando Health	Orlando	Florida
United States	Memorial Healthcare	Pembroke Pines	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	St. Mark's Hospital	Salt Lake City	Utah
United States	Spartanburg Regional Healthcare / Gibbs Cancer Center	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sirtex Medical

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  New Zealand,  Portugal,  Singapore,  Spain,  Taiwan, 

References & Publications (1)

van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodríguez J, Kröning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS defined as the time interval between the date of randomization and the date of death from any cause.	From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
Secondary	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.	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.