Therasphere® for behandling av ikke-opererbar primær leverkreft og metastatisk leverkreft
22. august 2017 oppdatert av: Leo W. Jenkins Cancer Center
En humanitær enhetsfritaksprotokoll for Therasphere® for behandling av ikke-opererbare hepatocellulære og metastatiske levertumorer - HDE #980006
Formålet med denne protokollen er å gi overvåket og begrenset tilgang til Therasphere®-behandling for pasienter med primær leverkreft og kjemoterapi refraktær levermetastaser som ikke kan behandles ved kirurgisk fjerning av den berørte delen av leveren.
Pasientens respons på behandlingen og eventuelle bivirkninger av Therasphere®-behandlingen vil bli undersøkt.
Studieoversikt
Status
Ikke lenger tilgjengelig
Intervensjon / Behandling
Studietype
Utvidet tilgang
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Greenville, North Carolina, Forente stater, 27834
- Leo W Jenkins Cancer Center at East Carolina University School of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
15 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
N/A
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- Bekreftet diagnose av primært eller metastatisk intrahepatisk karsinom
- Kreften må være uopererbar med begrensede etablerte behandlingsmuligheter
- ECOG ytelsesstatusscore 0-2
- Alder 19 år eller eldre
- Kunne forstå og gi skriftlig informert samtykke
Ekskluderingskriterier:
- Eventuelle laboratoriefunn før behandling innen 15 dager etter behandling som viser:
- Absolutt antall granulocytter ≤ 1500/ul
- Blodplateantall ≤ 75 000/ul
- Serumkreatinin > 2,0 mg/dl
- Serumbilirubin ≥ 2,0 mg/dl
- Enhver av følgende kontraindikasjoner for angiografi og selektiv visceral kateterisering:
- Anamnese med alvorlig allergi eller intoleranse mot kontrastmidler, narkotika, beroligende midler eller atropin
- Blødning, diatese, kan ikke korrigeres med vanlige former for terapi
- Alvorlig perifer vaskulær sykdom som vil utelukke kateterisering
- Betydelig venøs shunt vekk fra leveren
- Bevis for potensiell levering av mer enn 11 mCi (20 Gy absorbert dose) stråling til lungene ved enten 1) første Therasphere®-administrasjon; eller 2) kumulativ levering av stråling til lungene over flere behandlinger
- Bevis for påvisbar Tc-99 MAA-strøm til magen eller tolvfingertarmen, bruk av etablerte angiografiske teknikker for å stoppe slik strømning
- Betydelig ekstrahepatisk sykdom som representerer en overhengende livstruende situasjon
- Alvorlig leverdysfunksjon eller lungesvikt
- Aktiv ukontrollert infeksjon
- Betydelig underliggende medisinsk eller psykiatrisk sykdom
- Gravide kvinner kan ikke delta
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Suzanne Russo, MD, East Carolina University School of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. A comparison of lipiodol chemoembolization and conservative treatment for unresectable hepatocellular carcinoma. N Engl J Med. 1995 May 11;332(19):1256-61. doi: 10.1056/NEJM199505113321903.
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- SCHENK WG Jr, McDONALD JC, McDONALD K, DRAPANAS T. Direct measurement of hepatic blood flow in surgical patients: with related observations on hepatic flow dynamics in experimental animals. Ann Surg. 1962 Sep;156(3):463-71. doi: 10.1097/00000658-196209000-00013. No abstract available.
- Sasaki Y, Imaoka S, Kasugai H, Fujita M, Kawamoto S, Ishiguro S, Kojima J, Ishikawa O, Ohigashi H, Furukawa H, et al. A new approach to chemoembolization therapy for hepatoma using ethiodized oil, cisplatin, and gelatin sponge. Cancer. 1987 Sep 15;60(6):1194-203. doi: 10.1002/1097-0142(19870915)60:63.0.co;2-t.
- Yamada R, Kishi K, Sato M, Sonomura T, Nishida N, Tanaka K, Shioyama Y, Terada M, Kimura M. Transcatheter arterial chemoembolization (TACE) in the treatment of unresectable liver cancer. World J Surg. 1995 Nov-Dec;19(6):795-800. doi: 10.1007/BF00299773.
- Pelletier G, Roche A, Ink O, Anciaux ML, Derhy S, Rougier P, Lenoir C, Attali P, Etienne JP. A randomized trial of hepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma. J Hepatol. 1990 Sep;11(2):181-4. doi: 10.1016/0168-8278(90)90110-d.
- Uchida M, Kohno H, Kubota H, Hayashi T, Yamanoi A, Kimoto T, Ono T, Nagasue N. Role of preoperative transcatheter arterial oily chemoembolization for resectable hepatocellular carcinoma. World J Surg. 1996 Mar-Apr;20(3):326-31. doi: 10.1007/s002689900052.
- 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.
- Perry LJ, Stuart K, Stokes KR, Clouse ME. Hepatic arterial chemoembolization for metastatic neuroendocrine tumors. Surgery. 1994 Dec;116(6):1111-6; discussion 1116-7.
- 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.
- Mantravadi RV, Spigos DG, Tan WS, Felix EL. Intraarterial yttrium 90 in the treatment of hepatic malignancy. Radiology. 1982 Mar;142(3):783-6. doi: 10.1148/radiology.142.3.7063703. No abstract available.
- Herba MJ, Illescas FF, Thirlwell MP, Boos GJ, Rosenthall L, Atri M, Bret PM. Hepatic malignancies: improved treatment with intraarterial Y-90. Radiology. 1988 Nov;169(2):311-4. doi: 10.1148/radiology.169.2.3174978.
- 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.
- Stribley KV, Gray BN, Chmiel RL, Heggie JC, Bennett RC. Internal radiotherapy for hepatic metastases II: The blood supply to hepatic metastases. J Surg Res. 1983 Jan;34(1):25-32. doi: 10.1016/0022-4804(83)90018-5.
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- Leung TW, Lau WY, Ho SK, Ward SC, Chow JH, Chan MS, Metreweli C, Johnson PJ, Li AK. Radiation pneumonitis after selective internal radiation treatment with intraarterial 90yttrium-microspheres for inoperable hepatic tumors. Int J Radiat Oncol Biol Phys. 1995 Nov 1;33(4):919-24. doi: 10.1016/0360-3016(95)00039-3.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Datoer for studieregistrering
Først innsendt
17. juni 2008
Først innsendt som oppfylte QC-kriteriene
18. juni 2008
Først lagt ut (Anslag)
19. juni 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Adenokarsinom
- Karsinom
- Neoplasmer, kjertel og epitel
- Neoplasmer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer i leveren
- Neoplastiske prosesser
- Karsinom, hepatocellulært
- Neoplasma Metastase
Andre studie-ID-numre
- LJCC 07-04
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .