TheraSphere for the Treatment of Liver Metastases

Phase 2

Completed

Conditions: Colorectal Cancer
Neoplasm Metastasis
Carcinoma, Neuroendocrine

Interventions: Device: Yttrium 90 glass microspheres

Registration Number: NCT00511862

Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TheraSphere	Yttrium 90 glass microspheres	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

Primary Outcome Measures

Name	Time	Method
Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)	From the date of first treatment until date of first documented progression; median patient follow-up 30 months	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

Name	Time	Method
Overall Survival	Time from first TheraSphere treatment to death; median follow up 30 months	Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.

Trial Locations

Locations (5): John Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center
🇺🇸
Chicago, Illinois, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
Medical College of Wisconsin, Froedtert Hospital
🇺🇸
Milwaukee, Wisconsin, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States