Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
18. september 2019 opdateret af: Mi-Sook Kim, Korea Cancer Center Hospital
Phase II Multicenter Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Toxicity and Outcome
The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery.
In the remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence.
Recently several small studies reported high tumor response and local control rate after stereotactic body radiotherapy (SBRT) alone or with TACE for inoperable HCC.
A single institution phase II trial with SBRT for inoperable HCC after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall response rate of 73% and 2-year local control rate of 95%.
They reported severe gastrointestinal toxicity of 11% because there was no normal tissue constraint for gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest levels possible.
In addition, they found that the presence of gastroduodenal ulcer before SBRT was significantly influenced on severe gastrointestinal toxicity.
Based on this study, we will conduct a multicenter phase II trial on maintenance of treatment results and reduction of severe treatment related toxicity below 5%.
To achieve this, we strictly apply normal tissue constraints.
Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT to evaluate gastroduodenal ulcer.
After then, we will apply the normal tissue constraint of gastrointestinal tract according to gastroduodenal ulcer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
74
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Busan, Korea, Republikken, 612-896
- INJE University Haeundae Paik Hospital
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Busan, Korea, Republikken
- Dongnam Institute of Radiological & Medical Sciences
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Cheonan, Korea, Republikken
- Soon Chun Hyang University Hospital Cheonan
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Incheon, Korea, Republikken
- Inha University Hospital
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Incheon, Korea, Republikken
- Catholic University Incheon St. Mary's Hospital
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Seoul, Korea, Republikken
- Soon Chun Hyang University Hospital Seoul
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Seoul, Korea, Republikken, 139-706
- Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female patients ≥ 20 years of age
- Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
- Unresectable HCC
- Inaccessible to local ablative treatment
- Cirrhotic status of Child Pugh class A or B7
- Eastern Cooperative Oncology Group performance status 0 or 1
- Tumor size < 10cm
- The volume of uninvolved must be at least 700 ml
- Incomplete response after trans-arterial chemo-embolization of 1-5
- A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of SBRT
- No evidence of an uncontrolled lesion at any other site
- No evidence of complications of liver cirrhosis
- No evidence of uncontrolled inter-current illness
- Patient or guardian must be able to provide verbal and written informed consent
Exclusion Criteria:
- Patient with previous history of abdominal radiation
- Direct invasion to esophagus, stomach or colon by HCC
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Stereotactic body radiotherapy
Stereotactic body radiotherapy for unresectable hepatocellular carcinoma after incomplete trans-arterial chemo-embolization
|
Total stereotactic Body radiotherapy (SBRT) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by >48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of > 17 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of > 17 Gy. In patients without gastroduodenal ulcer on Esophagogastroduodenoscopy (EGD) before SBRT, D2ml of gastrointestinal tract should not exceed 35 Gy. In patients with gastroduodenal ulcer on EGD before SBRT, D2ml of gastrointestinal tract should exceed 28 Gy. (D2ml: minimum dose to 2 ml of gastrointestinal tract)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment related toxicity-free survival
Tidsramme: 1 year
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From the date of SBRT to the date of treatment related toxicity or last follow-up; Treatment related toxicity will be evaluated by the following criteria.
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall survival
Tidsramme: 2 years
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From the date of SBRT to the date of death or last follow-up
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2 years
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Progression free survival
Tidsramme: 2 years
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From the date of SBRT to the date of first failure or last follow-up
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2 years
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Intrahepatic recurrence free survival
Tidsramme: 2 years
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From the date of SBRT to the date of Intrahepatic recurrence or last follow-up
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2 years
|
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Patterns of failure
Tidsramme: 2 years
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Patterns of failure (local, intrahepatic, or systemic)
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2 years
|
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Systemic failure free survival
Tidsramme: 2 years
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From the date of SBRT to the date of systemin failure or last follow-up
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2 years
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Local control rate
Tidsramme: 2 years
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From the date of SBRT to the date of local failure or last follow-up
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2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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.
Studer store datoer
Studiestart (Faktiske)
1. januar 2012
Primær færdiggørelse (Faktiske)
1. april 2015
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
7. maj 2013
Først indsendt, der opfyldte QC-kriterier
8. maj 2013
Først opslået (Skøn)
9. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- K-1201-001-004 (Anden identifikator: [Registry ID: Clinical Research information Service)
- KCT0000454 (Registry Identifier: Clinical Research Information Service)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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