Therasphere® til behandling af ikke-operabel primær levercancer og metastatisk levercancer
22. august 2017 opdateret af: Leo W. Jenkins Cancer Center
En humanitær enhedsfritagelsesprotokol for Therasphere® til behandling af ikke-operable hepatocellulære og metastatiske levertumorer - HDE #980006
Formålet med denne protokol er at give overvåget og begrænset adgang til Therasphere®-behandling til patienter med primær levercancer og kemoterapi refraktær levermetastaser, som ikke kan behandles ved kirurgisk fjernelse af den berørte del af leveren.
Patientrespons på behandling og eventuelle bivirkninger af Therasphere®-behandling vil blive undersøgt.
Studieoversigt
Status
Ikke længere tilgængelig
Betingelser
Intervention / Behandling
Undersøgelsestype
Udvidet adgang
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Greenville, North Carolina, Forenede Stater, 27834
- Leo W Jenkins Cancer Center at East Carolina University School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Bekræftet diagnose af primært eller metastatisk intrahepatisk carcinom
- Kræften skal være uoperabel med begrænsede etablerede behandlingsmuligheder
- ECOG Performance Status Score 0-2
- Alder 19 år eller ældre
- Kan forstå og give skriftligt informeret samtykke
Ekskluderingskriterier:
- Alle laboratoriefund inden for 15 dage efter behandling, der viser:
- Absolut granulocyttal ≤ 1.500/ul
- Blodpladetal ≤ 75.000/ul
- Serumkreatinin > 2,0 mg/dl
- Serumbilirubin ≥ 2,0 mg/dl
- Enhver af følgende kontraindikationer til angiografi og selektiv visceral kateterisering:
- Anamnese med svær allergi eller intolerance over for kontrastmidler, narkotika, beroligende midler eller atropin
- Blødning, diatese, kan ikke korrigeres med sædvanlige former for terapi
- Alvorlig perifer vaskulær sygdom, der ville udelukke kateterisering
- Væsentlig venøs shunt væk fra leveren
- Bevis for potentiel levering af mere end 11 mCi (20 Gy absorberet dosis) stråling til lungerne ved enten 1) første Therasphere®-administration; eller 2) kumulativ levering af stråling til lungerne over flere behandlinger
- Beviser for påviselig Tc-99 MAA flow til maven eller tolvfingertarmen, anvendelse af etablerede angiografiske teknikker for at stoppe en sådan flow
- Betydelig ekstrahepatisk sygdom, der repræsenterer en overhængende livstruende situation
- Alvorlig leverdysfunktion eller pulmonal insufficiens
- Aktiv ukontrolleret infektion
- Betydelig underliggende medicinsk eller psykiatrisk sygdom
- Gravide kvinder må ikke deltage
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Suzanne Russo, MD, East Carolina University School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Stuart K, Stokes K, Jenkins R, Trey C, Clouse M. Treatment of hepatocellular carcinoma using doxorubicin/ethiodized oil/gelatin powder chemoembolization. Cancer. 1993 Dec 1;72(11):3202-9. doi: 10.1002/1097-0142(19931201)72:113.0.co;2-4.
- Berger DH, Carrasco CH, Hohn DC, Curley SA. Hepatic artery chemoembolization or embolization for primary and metastatic liver tumors: post-treatment management and complications. J Surg Oncol. 1995 Oct;60(2):116-21. doi: 10.1002/jso.2930600210.
- Vetter D, Wenger JJ, Bergier JM, Doffoel M, Bockel R. Transcatheter oily chemoembolization in the management of advanced hepatocellular carcinoma in cirrhosis: results of a Western comparative study in 60 patients. Hepatology. 1991 Mar;13(3):427-33.
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- Ehrhardt GJ, Day DE. Therapeutic use of 90Y microspheres. Int J Rad Appl Instrum B. 1987;14(3):233-42. doi: 10.1016/0883-2897(87)90047-x.
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- Blanchard RJ, Morrow IM, Sutherland JB. Treatment of liver tumors with yttrium-90 microspheres alone. Can Assoc Radiol J. 1989 Aug;40(4):206-10.
- Andrews JC, Walker SC, Ackermann RJ, Cotton LA, Ensminger WD, Shapiro B. Hepatic radioembolization with yttrium-90 containing glass microspheres: preliminary results and clinical follow-up. J Nucl Med. 1994 Oct;35(10):1637-44.
- BLANCHARD RJ, GROTENHUIS I, LAFAVE JW, PERRY JF Jr. BLOOD SUPPLY TO HEPATIC V2 CARCINOMA IMPLANTS AS MEASURED BY RADIOACTIVE MICROSPHERES. Proc Soc Exp Biol Med. 1965 Feb;118:465-8. doi: 10.3181/00379727-118-29876. No abstract available.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
17. juni 2008
Først indsendt, der opfyldte QC-kriterier
18. juni 2008
Først opslået (Skøn)
19. juni 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Karcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- Neoplasmer i leveren
- Neoplastiske processer
- Carcinom, hepatocellulært
- Neoplasma Metastase
Andre undersøgelses-id-numre
- LJCC 07-04
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 .