TheraSphere for the Treatment of Liver Metastases

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511862
• Other study ID #: G040148
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

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