Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy... | Recruiting
Efficacy Evaluation of TheraSphere ... | Recruiting
Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer
EPOCH

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Medical Conditions
  • Colorectal Cancer Metastatic
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01483027
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Device : TheraSphere

Study Arm Groups : Treatment group

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression free survival; From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
340
Participant Inclusion Criteria
    Inclusion Criteria

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

    - Not resected primary tumor; must be clinically stable

    - 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

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

    - 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

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

    - First line chemotherapy regimen completed 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

    - Neutrophil count >1200/cubic mm

    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

    - 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 (may resume after Y-90 treatment or immediately if in control arm)

    - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Southampton General Hospital
Southampton
England
SO16 6YD
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Guy's Hospital
London
SE1 9RT
Nottingham
Nottinghamshire
NG5 1PB
Guildford
GU2 7XX
London
NW1 2PG
Newcastle upon Tyne
NE7 7DN
Sheffield
S10 2SJ
Glasgow
G12 0YN
Site Reference ID/Investigator# 125695
Birkenhead
CH63 4JY
Churchhill Hospital
OX3 7LI
Beatson Cancer Centre and University of Glasgow
Glasgow,
G12 0YN
Royal Liverpool University Hospital
Liverpool,
L7 8XP
Trial Contact(s)
Primary Trial Contact
John Saliba
+79 81 881 6336
Other Trial Contacts
Judith Koehnen
+49 (0)221-80068367
Countries Recruiting
Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Korea, Republic of, Poland, Singapore, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy
EudraCT Number
Not available for this trial
Funder(s)
  • Biocompatibles UK Ltd
Other Study ID Numbers
TS-102
Sponsor(s)
BTG International Inc.
Key Dates

Recruitment Start Date

Jan 2012

Recruitment End Date

Sep 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

24 Nov 2011

Date updated in source

31 Aug 2017