Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

— EPOCH  

Official title:

A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483027
• Other study ID #: TS-102
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Must be male or female, 18 years of age or older, and of any ethnic or racial group

• If primary tumor has not been resected, it must be clinically stable

• Must have colorectal cancer with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression in the liver with oxaliplatin or irinotecan based first line chemotherapy

• Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen

• Must have baseline efficacy images with measurable target tumors in the liver according to RECIST 1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy

• Tumor replacement <50% of total liver volume

• Current Eastern Cooperative Oncology Group (ECOG) of 0-1 through screening to first treatment on study

• Will have completed the first line chemotherapy regimen at least 14 days prior to initiation of 2nd line chemotherapy under the protocol

• Patient is willing to participate in the study and has signed the study informed consent

• Serum creatinine = 2.0 mg/dL

• Serum bilirubin up to 1.2 x upper limit of normal

• Albumin = 3.0 g/dL

• Must have neutrophil count >1200/mm3 (1.2x109/L)

Exclusion Criteria

• History of hepatic encephalopathy

• Contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (eg. closure device)

• History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically

• Presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease

• Cirrhosis or portal hypertension

• Prior external beam radiation treatment to the liver

• Prior intra-arterial liver directed therapy, including transcatheter arterial chemoembolization (TACE) or Y-90 microsphere therapy

• Planned treatment with biological agents within 28 days prior to receiving TheraSphere

• Planned liver directed therapy or radiation therapy

• Intervention for, or compromise of, the Ampulla of Vater

• Clinically evident ascites (trace ascites on imaging is acceptable)

• Toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the safe treatment of the patient

• Significant life-threatening extra-hepatic disease, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be human immunodeficiency virus (HIV) positive or have acute hepatitis B virus (HBV) or hepatitis C virus (HCV)

• confirmed extra-hepatic metastases. Limited indeterminate extra-hepatic lesions in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion <1 cm; any number of lymph nodes with each individual nodes <1.5 cm)

• Contraindications to the planned second line standard-of-care chemotherapy regimen

• Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization, and must not be breastfeeding and must agree to use contraceptive for duration of study.

• Participation in a clinical trial with an investigational therapy within 30 days prior to randomization

• Co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Device:
• TheraSphere
yttrium 90 microspheres

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Belgium	Onze-Lieve-Vrouwziekenuis VZW Campus Aalst	Aalst
Belgium	AZ - Sint Lucas	Gent
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	AZ Groeninge	Kortrijk
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	QEII Health Services Center, Halifax Infirmary Site	Halifax	Nova Scotia
Canada	London Regional Cancer program	London	Ontario
Canada	McGill University Health Center - Glen Site	Montreal, Quebec	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network , Mount Sinai Hospital	Toronto	Ontario
China	Hong Kong Sanatorium Hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
France	CUH d'Angers	Angers	Cedex 9
France	Institut Bergognié	Bordeaux
France	Hôpital Beaujon	Clichy
France	Hôpital Henri Mondor	Créteil
France	Centre Georges Francois Leclerc	Dijon cedex
France	Centre Hospitalier Lyon-Sud	Lyon
France	Hôpital La Timone	Marseille
France	CHRU Montpellier - Hopital St Eloi	Montpellier	Cedex 5
France	CHU Nantes-Hôtel Dieu	Nantes
France	CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2	Nice
France	CHU Bordeaux	Pessac
France	Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie	Poitiers
France	Centre Eugene Marquis	Rennes
France	CHU Toulouse, Hôpital Rangueil	Toulouse	Cedex 9
Germany	Universitätsklinikum Bonn	Bonn,
Germany	Universitätsklinikum Essen	Essen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	SLK Kliniken, Heilbronn GmbH	Heilbronn
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	University Hospital of Leipzig	Leipzig
Germany	Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie	Marburg
Germany	Eberhard-Karls-University Tübingen	Tübingen
Italy	Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi	Bologna
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	St. Mary's Hospital	Seoul
Poland	Bialostockie Centrum Onkologii	Bialystok
Poland	Centrum Onkologii - Instytut, im. Marii Sklodowskiej-Curie	Gliwice
Poland	Regionalny Szpital Specjalistyczny im. Dr Wladyslawa Bieganskiego	Grudziadz
Poland	Oddzial Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Sw.Jana z Dukli.	Lublin
Poland	Szpital Kliniczny im. Heliodora Swiecickiego	Poznan
Poland	Centralny Szpital Kliniczny MSWiA	Warszawa
Poland	Centrum Onkologii - Instytut	Warszawa
Poland	Wojskowy Instytut Medyczny	Warszawa
Singapore	National University Hospital	Singapore
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona,
Spain	Hospital Universitario del Henares	Coslada
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Regional Universitario de Málaga - Hospital General	Malaga
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia,
Spain	Avenida de Roma, s/n, Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Parc Taulí Sabadell Hospital Universitari	Sabadell
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	HCU Lozano Blesa, Planta 11-Oncología-Secretaría	Zaragoza
United Kingdom	NHS Grampian - Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Royal United Hospital Bath NHS Trust	Bath
United Kingdom	The Clatterbrdige Cancer Centre NHSF Trust	Bebington
United Kingdom	Queen Elizabeth Hospital Cancer Centre	Birmingham
United Kingdom	The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital	Bournemouth
United Kingdom	University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital	Cambridge
United Kingdom	Velindre Cancer Centre	Cardiff
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	University of Glasgow	Glasgow
United Kingdom	Beatson Cancer Centre and University of Glasgow	Glasgow,
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary	Huddersfield
United Kingdom	Leeds Hospitals NHS Trust	Leeds
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	UCLH, University College London Hospitals	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Nottingham University Hospital NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Foundation Trust Churchill Hospital	Oxford
United Kingdom	Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital	Romford
United Kingdom	Western Park Hospital	Sheffield
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Great Western Hospitals NHS Foundation Trust - The Great Western Hospital	Swindon
United Kingdom	Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital	Taunton
United Kingdom	Walsall Healthcare NHS Trust - Manor Hospital	Walsall
United Kingdom	The Royal Wolverhampton NHS Trust - New Cross Hospital	Wolverhampton
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Colorado Denver Anschutz Medical Campus	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Lynn Clinical Research Center, Boca Raton Regional Hospital	Boca Raton	Florida
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University, Wexner Medical Center	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Miami Valley Hospital	Dayton	Ohio
United States	Wayne State Harper Hospita Karmanos Cancer Institute	Farmington Hills	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	UT MD Anderson Cancer Center	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Gundersen Medical Foundation	La Crosse	Wisconsin
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami Miller School of Medicine, Florida	Miami	Florida
United States	Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Allina Health, Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Minneapolis	Minneapolis	Minnesota
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Christiana Care Hospital	Newark	Delaware
United States	Sentara Norfolk General	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Mallinckrodt Institute of Radiology	Saint Louis	Missouri
United States	St. Marks Hospital	Salt Lake City	Utah
United States	University of California San Fransico, Moffitt Hospital	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Moffit Cancer Center	Tampa	Florida
United States	Aria Health	Trevose	Pennsylvania
United States	Carle Clinic	Urbana	Illinois
United States	Aurora Research Institute	Wauwatosa	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Biocompatibles UK Ltd

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  China,  France,  Germany,  Italy,  Korea, Republic of,  Poland,  Singapore,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Progression Free survival by blinded independent central review per RECIST 1.1	From date of randomization until the date of first documented progression, as defined by RECIST 1:1 or date of death from any cause, whichever comes first, assessed up to a minimum of 1 year follow up or until study completion
Primary	Hepatic Progression-Free Survival (HPFS)	Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1	Time from randomization until hepatic PD by BICR per RECIST 1.1 or death, whichever occurs first, assessed up to a minimum of 1 year follow up or study completion.
Secondary	Overall Survival	Time from randomization until date of death due to any cause as reported by study site.	Time from date of randomization until date of death due to any cause; patients remaining on study post progression were followed until study completion; duration of follow up could be a few months to several years depending on when event was met.