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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01483027
Other study ID # TS-102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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