Back to resultsTheraSphere for the Treatment of Liver Metastases
Primary Purpose
Colorectal Cancer, Carcinoma, Neuroendocrine, Neoplasm Metastasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yttrium 90 glass microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring TheraSphere, radioactive microspheres, Yttrium-90, Yttrium glass microspheres
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
- unresectable liver metastases
- target tumors measurable using standard imaging techniques
- tumor replacement < or = 50% of total liver volume (visual estimation by investigator)
- Hypervascular tumors (visual estimation by investigator)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer
- patient informed consent
Exclusion Criteria:
- At risk of hepatic or renal failure within 21 days of treatment (serum creatinine > 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any history of hepatic encephalopathy)
- contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
- severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
- cirrhosis or portal hypertension
- prior external beam radiation treatment to the liver
- prior TheraSphere treatment to the liver
- any intervention for, or compromise of the Ampulla of Vater
- clinically evident ascites (trace ascites on imaging is acceptable)
- any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment
- significant life-threatening extrahepatic disease in judgment of physician
- concurrent enrollment in another study
- alternative available therapies in judgement of physician
- evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30 Gy cumulative limit
- evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
- positive serum pregnancy test in women of childbearing potential
- co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
Sites / Locations
- Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center
- John Hopkins Hospital
- Mayo Clinic
- Albany Medical Center
- Medical College of Wisconsin, Froedtert Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TheraSphere
Arm Description
Single arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer
Outcomes
Primary Outcome Measures
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
Secondary Outcome Measures
Overall Survival
Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.
Full Information
NCT ID
NCT00511862
First Posted
August 2, 2007
Last Updated
April 19, 2021
Sponsor
Boston Scientific Corporation
Collaborators
BTG International Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00511862
Brief Title
TheraSphere for the Treatment of Liver Metastases
Official Title
TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
BTG International Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Carcinoma, Neuroendocrine, Neoplasm Metastasis
Keywords
TheraSphere, radioactive microspheres, Yttrium-90, Yttrium glass microspheres
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TheraSphere
Arm Type
Experimental
Arm Description
Single arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer
Intervention Type
Device
Intervention Name(s)
Yttrium 90 glass microspheres
Other Intervention Name(s)
TheraSphere
Intervention Description
120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe
Primary Outcome Measure Information:
Title
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
Description
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
Time Frame
From the date of first treatment until date of first documented progression; median patient follow-up 30 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.
Time Frame
Time from first TheraSphere treatment to death; median follow up 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
unresectable liver metastases
target tumors measurable using standard imaging techniques
tumor replacement < or = 50% of total liver volume (visual estimation by investigator)
Hypervascular tumors (visual estimation by investigator)
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer
patient informed consent
Exclusion Criteria:
At risk of hepatic or renal failure within 21 days of treatment (serum creatinine > 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any history of hepatic encephalopathy)
contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
cirrhosis or portal hypertension
prior external beam radiation treatment to the liver
prior TheraSphere treatment to the liver
any intervention for, or compromise of the Ampulla of Vater
clinically evident ascites (trace ascites on imaging is acceptable)
any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment
significant life-threatening extrahepatic disease in judgment of physician
concurrent enrollment in another study
alternative available therapies in judgement of physician
evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30 Gy cumulative limit
evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
positive serum pregnancy test in women of childbearing potential
co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al Benson III, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-4010
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Medical College of Wisconsin, Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TheraSphere for the Treatment of Liver Metastases
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