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

NCT01483027 | Completed Results DMC

• 1 other identifier: TS-102
• Study Type: interventional
• Target: 428
• Locations: 13 countries
• Sites: 131

Brief 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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Overall Survival

  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.

Study Arms (2)

Treatment group

EXPERIMENTAL

Standard of care second-line chemotherapy plus TheraSphere

Device: TheraSphere

Control group

NO INTERVENTION

Standard of care second-line chemotherapy with no added therapy

Interventions

TheraSphere DEVICE

yttrium 90 microspheres

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (131)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of California San Fransico, Moffitt Hospital

San Francisco, California, 94143, United States

Location

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Christiana Care Hospital

Newark, Delaware, 19713, United States

Location

Lynn Clinical Research Center, Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

University of Miami Miller School of Medicine, Florida

Miami, Florida, 33136, United States

Location

Moffit Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Carle Clinic

Urbana, Illinois, 61801, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Wayne State Harper Hospita Karmanos Cancer Institute

Farmington Hills, Michigan, 48334, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Allina Health, Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Minneapolis

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Aria Health

Trevose, Pennsylvania, 19053, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

St. Marks Hospital

Salt Lake City, Utah, 84124, United States

Location

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Gundersen Medical Foundation

La Crosse, Wisconsin, 54601, United States

Location

Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Aurora Research Institute

Wauwatosa, Wisconsin, 53226, United States

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Onze-Lieve-Vrouwziekenuis VZW Campus Aalst

Aalst, 9300, Belgium

Location

AZ - Sint Lucas

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

QEII Health Services Center, Halifax Infirmary Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

London Regional Cancer program

London, Ontario, N6A 4L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network , Mount Sinai Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Health Center - Glen Site

Montreal, Quebec, Quebec, H4A 3J1, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Hong Kong Sanatorium Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

CHRU Montpellier - Hopital St Eloi

Montpellier, Cedex 5, 34295, France

Location

CUH d'Angers

Angers, Cedex 9, 49933, France

Location

CHU Toulouse, Hôpital Rangueil

Toulouse, Cedex 9, 31059, France

Location

Institut Bergognié

Bordeaux, 33076, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Centre Georges Francois Leclerc

Dijon, 21000, France

Location

Centre Hospitalier Lyon-Sud

Lyon, 69003, France

Location

Hôpital La Timone

Marseille, 13005, France

Location

CHU Nantes-Hôtel Dieu

Nantes, 44093, France

Location

CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2

Nice, 6202, France

Location

CHU Bordeaux

Pessac, 33600, France

Location

Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie

Poitiers, 86000, France

Location

Centre Eugene Marquis

Rennes, 35000, France

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

SLK Kliniken, Heilbronn GmbH

Heilbronn, 74078, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

University Hospital of Leipzig

Leipzig, 04103, Germany

Location

Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie

Marburg, 35043, Germany

Location

Eberhard-Karls-University Tübingen

Tübingen, 72076, Germany

Location

Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

Białostockie Centrum Onkologii

Bialystok, Poland

Location

Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie

Gliwice, Poland

Location

Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego

Grudziądz, Poland

Location

Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.

Lublin, Poland

Location

Szpital Kliniczny im. Heliodora Święcickiego

Poznan, Poland

Location

Centralny Szpital Kliniczny MSWiA

Warsaw, Poland

Location

Centrum Onkologii - Instytut

Warsaw, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, Poland

Location

National University Hospital

Singapore, 119228, Singapore

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

St. Mary's Hospital

Seoul, South Korea

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, 28922, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario del Henares

Coslada, 28822, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, 28942, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28220, Spain

Location

Hospital Regional Universitario de Málaga - Hospital General

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Avenida de Roma, s/n, Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Parc Taulí Sabadell Hospital Universitari

Sabadell, 8208, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

HCU Lozano Blesa, Planta 11-Oncología-Secretaría

Zaragoza, 50009, Spain

Location

NHS Grampian - Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Royal United Hospital Bath NHS Trust

Bath, BA1 3NG, United Kingdom

Location

The Clatterbrdige Cancer Centre NHSF Trust

Bebington, CH63 4JY, United Kingdom

Location

Queen Elizabeth Hospital Cancer Centre

Birmingham, B15 2TH, United Kingdom

Location

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Beatson Cancer Centre and University of Glasgow

Glasgow, G12 0YN, United Kingdom

Location

University of Glasgow

Glasgow, G12 0YN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary

Huddersfield, HD3 3EA, United Kingdom

Location

Leeds Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

UCLH, University College London Hospitals

London, NW1 2PG, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

Location

Nottingham University Hospital NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust Churchill Hospital

Oxford, OX3 7LI, United Kingdom

Location

Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital

Romford, RM7 0AG, United Kingdom

Location

Western Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Great Western Hospitals NHS Foundation Trust - The Great Western Hospital

Swindon, SN3 6BB, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

Walsall Healthcare NHS Trust - Manor Hospital

Walsall, WS2 9PS, United Kingdom

Location

The Royal Wolverhampton NHS Trust - New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (3)

• Salem R, Garin E, Boucher E, Fowers K, Lam M, Padia S, Harris W. Optimal patient selection for yttrium-90 glass plus chemotherapy in the treatment of colorectal liver metastases: additional quality of life, efficacy, and safety analyses from the EPOCH study. Oncologist. 2024 Aug 5;29(8):681-689. doi: 10.1093/oncolo/oyae128.

  PMID: 38985849 DERIVED

• Mulcahy MF, Mahvash A, Pracht M, Montazeri AH, Bandula S, Martin RCG 2nd, Herrmann K, Brown E, Zuckerman D, Wilson G, Kim TY, Weaver A, Ross P, Harris WP, Graham J, Mills J, Yubero Esteban A, Johnson MS, Sofocleous CT, Padia SA, Lewandowski RJ, Garin E, Sinclair P, Salem R; EPOCH Investigators. Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. J Clin Oncol. 2021 Dec 10;39(35):3897-3907. doi: 10.1200/JCO.21.01839. Epub 2021 Sep 20.

  PMID: 34541864 DERIVED

• Chauhan N, Mulcahy MF, Salem R, Benson Iii AB, Boucher E, Bukovcan J, Cosgrove D, Laframboise C, Lewandowski RJ, Master F, El-Rayes B, Strosberg JR, Sze DY, Sharma RA. TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial. JMIR Res Protoc. 2019 Jan 17;8(1):e11545. doi: 10.2196/11545.

  PMID: 30664496 DERIVED

Limitations and Caveats

For the event of death noted as "other" this is how it was captured in our database due to fact that it was a death "unknown cause" and there is no related SAE. It is captured as an event under All Cause Mortality table.

Results Point of Contact

• Title: Chantal Laframboise
• Organization: Boston Scientific

chantal.laframboise@bsci.com

+1 613 882 0876

Study Officials

• Mary F Mulcahy, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: December 1, 2011
• Study Start: January 1, 2012
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 29, 2022
• Results First Posted: March 29, 2022

Record last verified: 2022-03

Locations

DE (8); BE (4); FR (14); IT (1); US (35); AU (1); PL (8); KR (5); SG (1); ES (18); CA (7); CN (2); GB (27)