Clinical trial NCT00511862: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Carcinoma, Neuroendocrine
Neoplasm Metastasis
Keywords: TheraSphere
radioactive microspheres
Yttrium-90
Yttrium glass microspheres
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: BTG International Inc.
First posted: 2007-08-06
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)
timeFrame: From the date of first treatment until date of first documented progression; median patient follow-up 30 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Time from first TheraSphere treatment to death; median follow up 30 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Northwestern University
name: Al Benson III, MD
role: PRINCIPAL_INVESTIGATOR
References: