- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00109954
Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
|---|
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Brian I. Carr, MD, University of Pittsburgh
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PCI-04128
- CDR0000425333 (Registry Identifier: PDQ (Physician Data Query))
- PCI-IRB-0501021
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Leverkræft
-
National Health Research Institutes, TaiwanRekrutteringMindfulness | Senlivsdepression | Voksne for sent liv | Prodromal depression af sent liv | HjernestimuleringsinterventionTaiwan
-
Universidad Complutense de MadridRekruttering
-
L'OrealRekrutteringPigmentering fra det virkelige livIndien
-
Université de Reims Champagne-ArdenneAfsluttetAdolescentes følelsesmæssige og seksuelle livFrankrig
-
Sisli Hamidiye Etfal Training and Research HospitalIkke rekrutterer endnu
-
Bournemouth UniversityDorset County Hospital NHS Foundation TrustAfsluttetErfaring, livDet Forenede Kongerige
-
University of California, Los AngelesVA Greater Los Angeles Healthcare SystemTrukket tilbageVeteranfamilier | Familiekommunikation | Civilt liv reintegrationForenede Stater
-
Swiss Federal Institute of TechnologyAfsluttetÆldret | Uafhængigt livSchweiz
-
Diakonie Kliniken ZschadraßChemnitz University of TechnologyAfsluttetMantra meditation | Mantra Meditation + Kropsorienteret Yoga | Mantra Meditation + Etisk Liv | Mantra Meditation + Kropsorienteret Yoga + Etisk LivTyskland
-
CalydialOZ'IRIS SantéAfsluttetPatientengagement | Patientdeltagelse | Patienttilfredshed | Dialyse | Patientforhold, Sygeplejerske | Erfaring, livFrankrig
Kliniske forsøg med cisplatin
-
West China Second University HospitalRekrutteringNeoadjuverende kemoterapi | Epitelkarcinom, ovarieKina
-
Insmed IncorporatedAfsluttetOsteosarkom MetastatiskForenede Stater
-
Privo TechnologiesNational Cancer Institute (NCI)AfsluttetOralt planocellulært karcinomForenede Stater
-
London Health Sciences Centre Research Institute...RekrutteringLokalt avanceret hoved- og halspladecellekarcinomCanada
-
Taiho Oncology, Inc.Quintiles, Inc.AfsluttetMavekræftForenede Stater, Canada
-
Cedars-Sinai Medical CenterAktiv, ikke rekrutterendeHPV-positivt orofaryngealt planocellulært karcinomForenede Stater
-
Sun Yat-sen UniversityAktiv, ikke rekrutterendeNasopharyngealt karcinomKina
-
Fujian Cancer HospitalIkke rekrutterer endnuNasopharyngealt karcinomKina
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...Afsluttet
-
Taiho Pharmaceutical Co., Ltd.AfsluttetLivmoderhalskræftJapan, Korea, Republikken, Taiwan