Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00469963

Purpose

RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery.

Condition	Intervention
Liver Cancer	Drug: yttrium Y 90 resin microspheres Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Tumor response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Health-related quality of life [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	December 2003

Detailed Description:

OBJECTIVES:

Primary

Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with unresectable primary hepatocellular carcinoma.

Secondary

Determine the toxicity of this regimen in these patients.
Determine the health-related quality of life of patients receiving this regimen.
Determine the survival of patients receiving this regimen.

OUTLINE: Patients undergo selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) via catheter directly into the hepatic artery on day 1.

Health-related quality of life is assessed prior to initial treatment and then periodically thereafter.

After completion of study treatment, patients are followed periodically for 12-24 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of hepatocellular carcinoma
- Not amenable to surgical resection or immediate liver transplantation
  - Destaging of tumor prior to surgical resection or transplantation allowed
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan
- No equivocal, nonmeasurable, or nonevaluable liver cancer
No more than 75% replacement of normal liver by tumor
Cancer of the Liver Italian Program (CLIP) stage 1-3 disease
No extra-hepatic metastases as determined by CT scan or MRI

PATIENT CHARACTERISTICS:

Life expectancy ≥ 3 months
Karnofsky performance status 50-100%
Creatinine ≤ 1.5 mg/dL
Bilirubin ≤ 2.0 mg/dL
Albumin ≥ 3 g/dL
Granulocyte count ≥ 1,500/mm³
Platelet count ≥ 65,000/mm³
INR ≤ 1.4
Hemoglobin > 9 g/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No nonmalignant disease that would render the patient ineligible for treatment according to this protocol
No hepatic arterial anatomy that would prevent the administration of study drug into the liver
Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated albumin nuclear scan
No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 90 days since prior surgery, chemotherapy, or locally ablative technique for the liver cancer
More than 4 weeks since prior and no other concurrent investigational drug or agent/procedure (i.e., participation in another trial)
No prior radiotherapy to the upper abdomen that included the liver in the treatment field
No capecitabine within 8 weeks before or after study treatment
No other anticancer treatment (except surgical resection) for liver cancer during and for 3 months after completion of study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469963

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Steven G. Meranze, MD

Vanderbilt-Ingram Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000543832, VU-VICC-GI-0364
Study First Received:	May 3, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00469963
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Recurrence
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009