Clinical trial NCT00469963: Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Official title: Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
advanced adult primary liver cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Tumor response
timeFrame: up to 12 months
Secondary outcomes:
measure: Toxicity
timeFrame: up to 3 months
measure: Health-related quality of life
timeFrame: prior to initial treatment.
measure: Survival
timeFrame: trial entry to death
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Steven G. Meranze, MD
role: PRINCIPAL_INVESTIGATOR
References: