TheraSphere for the Treatment of Liver Metastases

NCT ID: NCT00511862

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-03-31

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.

Conditions

Colorectal Cancer; Carcinoma, Neuroendocrine; Neoplasm Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TheraSphere

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

Group Type: EXPERIMENTAL

Yttrium 90 glass microspheres

Intervention Type: DEVICE

120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe

Interventions

Yttrium 90 glass microspheres

120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe

Intervention Type: DEVICE

Other Intervention Names

TheraSphere

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BTG International Inc.

OTHER

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Al Benson III, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

John Hopkins Hospital

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Albany Medical Center

Albany, New York, United States

Medical College of Wisconsin, Froedtert Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

G040148

Identifier Type: -

Identifier Source: org_study_id