Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study. (KARCHER-1)

4. juli 2022 opdateret af: University Hospital, Lille

A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.

Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".

To adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients.

Stereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment.

Given the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Lille, Frankrig, 59037
        • Rekruttering
        • Hop Claude Huriez Chu Lille

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

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria
  • Single nodule, 3 to 8 cm of largest diameter
  • Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization

Exclusion Criteria:

  • Performance status > 2
  • Severe comorbidity with contraindication for either surgery or radiation therapy
  • Decompensated liver cirrhosis (Child-Pugh B or C)
  • Neoplastic portal vein thrombosis or extra-hepatic metastases
  • Previous anticancer therapy within the last 5 years

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
Eksperimentel: Eksperimentel gruppe
Kombinationsprodukt: Surgery with Neoadjuvant stereotactic body radiation therapy
Stereotactic hypofractionated robotic radiation therapy (24-45 Gy / 3 fractions) followed after 4-6 weeks by conventional hepatectomy (either anatomical liver resection, or non-anatomical liver resection with intention to achieve a minimal 2 cm margin).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Drop-out rate
Tidsramme: Five months after the inclusion of the last participating patient

Drop-out rate: proportion of patients in whom surgical resection cannot be achieved, due to (at least one of the following reasons):

  • serious adverse events related to radiation therapy (especially liver decompensation);
  • disease progression while receiving radiation therapy or awaiting surgery;
  • patient's death.
Five months after the inclusion of the last participating patient

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative number of packed red blood cells transfused (if any).
Tidsramme: Postoperative 90 days
Postoperative 90 days
Toxicity of radiation therapy using the National Cancer Institute CTCAE v.5.0 criteria
Tidsramme: Postoperative 90 days
Postoperative 90 days
Duration of surgery.
Tidsramme: Postoperative 90 days
Postoperative 90 days
Volume of intraoperative blood loss
Tidsramme: Postoperative 90 days
Postoperative 90 days
Quality of life by EORTC QLQ-C30
Tidsramme: between before and after stereotactic radiotherapy
between before and after stereotactic radiotherapy
Intraoperative adverse events
Tidsramme: Postoperative 90 days
Postoperative 90 days
Postoperative severe and overall morbidity rate
Tidsramme: Postoperative 90 days
defined using the Comprehensive Complication Index and graded with the Dindo-Clavien score
Postoperative 90 days
Postoperative mortality rate.
Tidsramme: Postoperative 90 days
Postoperative 90 days
Correlation between radiological observations on preoperative imaging and pathological features on surgical specimen (like percentage of tumor necrosis).
Tidsramme: Postoperative day 30.
Postoperative day 30.
Actuarial overall survival and disease-free survival.
Tidsramme: Postoperative 24 months
Postoperative 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Lille

Samarbejdspartnere

Ministry of Health, France

Efterforskere

  • Ledende efterforsker: Emmanuel Boleslawski, MD,PhD, University Hospital, Lille

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)

31. januar 2021

Primær færdiggørelse (Forventet)

1. januar 2024

Studieafslutning (Forventet)

1. januar 2024

Datoer for studieregistrering

Først indsendt

13. oktober 2020

Først indsendt, der opfyldte QC-kriterier

13. oktober 2020

Først opslået (Faktiske)

14. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2017_03
  • 2019-A01441-56 (Anden identifikator: ID-RCB number,ANSM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 Hepatocellulært karcinom

Kliniske forsøg med Surgery with Neoadjuvant stereotactic body radiation therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner