Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
18. september 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
74
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Busan, Korea, Republikken, 612-896
- Inje University Haeundae Paik Hospital
-
Busan, Korea, Republikken
- Dongnam Institute of Radiological & Medical Sciences
-
Cheonan, Korea, Republikken
- Soon Chun Hyang University Hospital Cheonan
-
Incheon, Korea, Republikken
- Inha University Hospital
-
Incheon, Korea, Republikken
- Catholic University Incheon St. Mary's Hospital
-
Seoul, Korea, Republikken
- Soon Chun Hyang University Hospital Seoul
-
Seoul, Korea, Republikken, 139-706
- Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
-
-
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
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment related toxicity-free survival
Tidsramme: 1 year
|
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.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: 2 years
|
From the date of SBRT to the date of death or last follow-up
|
2 years
|
|
Progression free survival
Tidsramme: 2 years
|
From the date of SBRT to the date of first failure or last follow-up
|
2 years
|
|
Intrahepatic recurrence free survival
Tidsramme: 2 years
|
From the date of SBRT to the date of Intrahepatic recurrence or last follow-up
|
2 years
|
|
Patterns of failure
Tidsramme: 2 years
|
Patterns of failure (local, intrahepatic, or systemic)
|
2 years
|
|
Systemic failure free survival
Tidsramme: 2 years
|
From the date of SBRT to the date of systemin failure or last follow-up
|
2 years
|
|
Local control rate
Tidsramme: 2 years
|
From the date of SBRT to the date of local failure or last follow-up
|
2 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2012
Primær fullføring (Faktiske)
1. april 2015
Studiet fullført (Faktiske)
1. september 2017
Datoer for studieregistrering
Først innsendt
7. mai 2013
Først innsendt som oppfylte QC-kriteriene
8. mai 2013
Først lagt ut (Anslag)
9. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K-1201-001-004 (Annen identifikator: [Registry ID: Clinical Research information Service)
- KCT0000454 (Registeridentifikator: Clinical Research Information Service)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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. .