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

15 januari 2016 bijgewerkt door: Weijing Sun, MD, FACP, University of Pittsburgh

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)

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

120

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 120 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Progression-free survival as assessed by tumor progression in the treated lobe of the liver
Health-related quality of life at baseline and every 3 months
Toxicity as measured by NCI CTCAE version 3.0

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Brian I. Carr, MD, University of Pittsburgh

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2005

Primaire voltooiing (Werkelijk)

1 december 2005

Studie voltooiing (Werkelijk)

1 december 2005

Studieregistratiedata

Eerst ingediend

3 mei 2005

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2005

Eerst geplaatst (Schatting)

4 mei 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

18 januari 2016

Laatste update ingediend die voldeed aan QC-criteria

15 januari 2016

Laatst geverifieerd

1 maart 2015

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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