Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery - Full Text View

Sponsors and Collaborators:	UPMC Cancer Centers National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00109954

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. In this case, chemotherapy is given through the artery (hepatic artery) that brings blood to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic arterial chemoembolization with cisplatin is more effective than internal radiation therapy in treating liver cancer.

PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with cisplatin to see how well it works compared to internal radiation therapy in treating patients with advanced liver cancer that cannot be removed by surgery.

Condition	Intervention	Phase
Liver Cancer	Drug: cisplatin Radiation: brachytherapy Radiation: yttrium Y 90 glass microspheres	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Prospectively Randomized Controlled Clinical Trial Comparing TheraSphere With Cisplatin-Based TACE (Trans Arterial Chemo Embolization) in the Management of Advanced Stage, Unresectable Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer Radiation Therapy Surgery

Drug Information available for: Cisplatin TheraSphere

U.S. FDA Resources

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

Primary Outcome Measures:

Progression-free survival as assessed by tumor progression in the treated lobe of the liver [ Designated as safety issue: No ]
Health-related quality of life at baseline and every 3 months [ Designated as safety issue: No ]
Toxicity as measured by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	February 2005

Detailed Description:

OBJECTIVES:

Primary

Compare time to disease progression in patients with unresectable advanced hepatocellular carcinoma treated with cisplatin-based trans-arterial chemoembolization vs hepatic intra-arterial yttrium Y 90 glass microspheres (TheraSphere®).
Compare the health-related quality of life of patients treated with these regimens.
Compare the safety of these regimens in these patients.

Secondary

Compare survival of patients treated with these regimens.
Compare tumor response by CT scan in patients treated with these regimens.
Compare treatment-related costs, in terms of cost of therapy and number of hospitalization days, in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to extent of tumor in the liver (< 50% vs ≥ 50%) and presence of portal hypertension (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo trans-arterial chemoembolization comprising intra-arterial (IA) infusion of cisplatin over 30-60 minutes followed by embolization of the hepatic artery (that brings blood to the tumor) on day 1.

Treatment repeats every 8-10 weeks in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive yttrium Y 90 glass microspheres (TheraSphere®) IA on day 1. Beginning 60 days after the first TheraSphere® treatment, patients may receive additional treatment with TheraSphere® only if follow-up CT scans show progressive disease. Quality of life is assessed at baseline and then every 3 months thereafter.

After the completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
  - Confined to the liver
- Vascular liver mass in the presence of cirrhosis
  - Alpha-fetoprotein level > 500 ng/mL
Measurable disease
- At least 1 unidimensionally measurable lesion > 20 mm by spiral CT scan
Unresectable disease, due to tumor size or extent or presence of cirrhosis
No metastatic disease, including brain metastases
- Locoregional lymph node metastases allowed
No evidence of potential delivery of > 16.5 miCi (30 Gy absorbed dose) of radiotherapy to the lungs either during the first administration of yttrium Y 90 glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs over multiple treatments*
No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop the flow* NOTE: *For patients randomized to the TheraSphere® arm only

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

More than 12 weeks

Hematopoietic

WBC > 2,500/mm^3
Absolute neutrophil count > 1,500/mm^3
Platelet count > 60,000/mm^3
No bleeding diathesis not correctable by usual forms of therapy

Hepatic

See Disease Characteristics
Bilirubin < 2.0 mg/dL
AST and/or ALT ≤ 5 times upper limit of normal
Hepatitis allowed
No portal hypertension with hepatofugal flow

Renal

Creatinine < 2.5 mg/dL

Cardiovascular

No symptomatic congestive heart failure
No severe peripheral vascular disease that would preclude catheterization

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double barrier or hormonal contraception during and for at least 30 days after completion of study treatment
No ongoing or active infection
No other uncontrolled illness
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No more than 1 prior systemic chemotherapy for HCC
More than 4 weeks since prior IV chemotherapy and recovered
More than 1 year since prior hepatic arterial cisplatin
More than 4 months since other prior hepatic arterial chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior external hepatic radiotherapy for HCC

Surgery

Not specified

Other

No other concurrent therapy for HCC
No other concurrent investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109954

Locations

United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

UPMC Cancer Centers

National Cancer Institute (NCI)

Investigators

Study Chair:

Brian I. Carr, MD

UPMC Cancer Centers

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000425333, PCI-04128, PCI-IRB-0501021
Study First Received:	May 3, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00109954 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Recurrence
Carcinoma
Liver Neoplasms
Methamphetamine
Digestive System Diseases

Radiation-Sensitizing Agents
Cisplatin
Gastrointestinal Neoplasms
Amphetamine
Adenocarcinoma
Hepatocellular Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Carcinoma, Hepatocellular
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Liver Neoplasms

Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009