Back to results

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

Primary Purpose

Liver Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

quality-of-life assessment

yttrium Y 90 resin microspheres

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, advanced adult primary liver cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIR-SPHERES

Arm Description

Outcomes

Primary Outcome Measures

Tumor response

All uni-dimensional measurable lesions (longest diameter >20mm with conventional techniques and >10mm with spiral CT scans) up to a maximum of five lesions per organ with a maximum of 10 lesions in total are used to determine response.

Secondary Outcome Measures

Toxicity

Health-related quality of life

The assessment will include a Karnofsky score the patient-completed SF-36 questionnaire. This information will be assessed at each quarterly evaluation, as well as any unscheduled clinical appointments. Karnofsky functional performance36 will be assessed by a clinician. This widely-used scale ranges from 0 to 100 and derives three broad categories of functional performance (able: 80-100; unable: 50-70; and disabled: 0-40). Patient report of HRQOL will be determined via the Medical Outcome Study 36-item short form (SF-36)37, which includes eight individual scales, physical and mental component summary scores, and is normed to both healthy and clinical populations.

Survival

Full Information

NCT ID

NCT00469963

First Posted

May 3, 2007

Last Updated

August 31, 2012

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00469963

Brief Title

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

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Terminated

Why Stopped

slow accrual

Study Start Date

December 2003 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SIR-SPHERES

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Description

quality-of-life assessment

Intervention Type

Radiation

Intervention Name(s)

yttrium Y 90 resin microspheres

Other Intervention Name(s)

radiation therapy

Intervention Description

radiation therapy

Primary Outcome Measure Information:

Title

Tumor response

Description

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Toxicity

Time Frame

up to 3 months

Title

Health-related quality of life

Description

Time Frame

prior to initial treatment.

Title

Survival

Time Frame

trial entry to death

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven G. Meranze, MD

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6838

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs