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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00511862
Other study ID # G040148
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2007
Est. completion date March 2011

Study information

Verified date April 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Yttrium 90 glass microspheres
120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe

Locations

Country Name City State
United States Albany Medical Center Albany New York
United States John Hopkins Hospital Baltimore Maryland
United States Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center Chicago Illinois
United States Medical College of Wisconsin, Froedtert Hospital Milwaukee Wisconsin
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Boston Scientific Corporation BTG International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From the date of first treatment until date of first documented progression; median patient follow-up 30 months
Secondary Overall Survival Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive. Time from first TheraSphere treatment to death; median follow up 30 months
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