Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

NCT00530010 | Completed DMC

• 3 other identifiers: NU 1365-001P30CA060553NU-1365-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Patient Completion

  Proportion of patients completing scheduled treatment plan

  Through study completion, up to 24 months or when patient discontinues treatment for whatever reason.

Interventions

yttrium Y 90 glass microspheres RADIATION

The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable cancer primarily in the liver with the liver being the only site of disease or the dominant site of disease

You may qualify if:

• ECOG performance status 0-2
• Absolute granulocyte count ≥ 1,500/μL
• Platelet count \> 25,000/μL
• Serum creatinine \< 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)
• Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

You may not qualify if:

• Any of the following contraindications to angiography and selective visceral catheterization:
• History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques
• Bleeding diathesis, not correctable by usual forms of therapy
• Severe peripheral vascular disease that would preclude catheterization
• Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• PRIOR CONCURRENT THERAPY:
• At least 4 weeks since prior and no other concurrent anticancer therapy

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Related Publications (1)

• Salem R, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Ibrahim S, Atassi B, Baker T, Gates V, Miller FH, Sato KT, Wang E, Gupta R, Benson AB, Newman SB, Omary RA, Abecassis M, Kulik L. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology. 2010 Jan;138(1):52-64. doi: 10.1053/j.gastro.2009.09.006. Epub 2009 Sep 18.

  PMID: 19766639 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Riad Salem, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: December 1, 2004
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

US (1)