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Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma

20 juni 2018 bijgewerkt door: University of Michigan Rogel Cancer Center

A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma

This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).

This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which local ablative modality is most appropriate for which patients. This study will also provide important information regarding quality of life and liver function changes following these two different treatment modalities.

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • The University of Michigan Comprehensive Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patients with hepatocellular carcinoma (HCC) are eligible for this trial. HCC is defined as having at least one of the following:

    1. HCC diagnosed either on biopsy or based on standard imaging criteria on contrast enhanced CT or MRI (arterial enhancement with washout and pseudocapsule); or
    2. A discrete hepatic tumor(s) as defined by the Barcelona criteria10 for cirrhotic patients, >1 cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI
    3. Presentation at multidisciplinary liver tumor board to assess eligibility for either SBRT or MWA
  • Patients must have 1-2 intrahepatic foci of HCC and may not be candidates for refuse hepatic resection. Patients who are on the organ wait list for (orthotopic liver transplantation) OLT will be considered for this trial as a "bridge" to transplant.
  • Patients with 1 focus of HCC will be eligible if their tumor is 3.5 cm or less in greatest diameter. Patients with 2 foci of HCC will be eligible if each lesion is 3.5 cm in diameter or less and the combined diameter of both lesions is 5 cm or less.
  • The foci of HCC must be in an anatomic location amendable to treatment by both MWA and SBRT.
  • The patient must have an ECOG performance status of ≤ 2 (Eastern Cooperative Oncology Group Performance Status is an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death).
  • Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, MWA or TACE) and a minimum of 4 weeks must have passed since the last procedure and protocol therapy.

  • Patients must have:

    1. Platelets ≥ 50,000/mm3
    2. Child Pugh class A liver function or class B7 (Appendix II)
    3. INR (international normalized ratio (for anticoagulant monitoring)) < 1.5
  • The patient must have a life expectancy of at least 12 weeks
  • The patient must be at least 18 years old
  • Patients must sign an IRB approved informed consent form for this purpose indicating that they are aware of the investigational aspects of the treatment and the potential risks. They also must be able to understand and the willing to sign a written informed consent.

Exclusion Criteria:

  • Patients who have received prior abdominal radiation
  • Patients with 3 or more foci of HCC
  • Patients whose HCC involves the local vasculature, regional lymph nodes or distant metastatic sites
  • Patients with Child Pugh liver function worse than B7

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MWA
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
Straling: Microwave Ablation (MWA)
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
Experimenteel: SBRT
SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.
Straling: Stereotactic Body Radiation Therapy (SBRT)
SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to local tumor progression
Tijdsspanne: Patients will be followed up to 2 years
The primary outcome of this trial is to prospectively determine local control rates in patients with HCC treated with MWA or SBRT. Freedom From Local Progression (FFLP) is defined as the time from randomization to local tumor progression. Tumors falling to group PD (progressive disease) would constitute local control failures. Progressive disease will be defined as at least a 20% increase in the LD (longest diameter) of target lesion, taking as reference the smallest LD recorded. Or at least a 20% increase in viable arterial enhancing disease, taking as reference the smallest LD of viable HCC since treatment started. Increases of less than 3 mm compared to the smallest LD recorded will be considered stable disease rather than PD.
Patients will be followed up to 2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of gastrointestinal (GI) and hepatobiliary toxicity
Tijdsspanne: Patients will be followed up to 2 years
The number of patients experiencing grade 3 or higher GI or hepatobiliary toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Patients will be followed up to 2 years
Incidence of liver function worsening
Tijdsspanne: Patients will be followed up to 2 years
The number of patients experiencing a 2 point or more increase in Child-Pugh score and an increase in albumin-bilirubin score of at least 0.5.
Patients will be followed up to 2 years
Change in FACT- Hep questionnaire score
Tijdsspanne: Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
The FACT-Hep questionnaire is used to measure health-related quality of life (HRQoL) in patients with hepatobiliary cancers. They are asked questions about their physical, social, emotional and functional well-being and asked to provide a score between 0 and 4 where 0 represents not at all and 4 represents very much.
Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
Overall survival time
Tijdsspanne: Patients will be followed up to 2 years
Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at last follow-up will be censored on that date.
Patients will be followed up to 2 years
Progression free survival time
Tijdsspanne: Patients will be followed up to 2 years
Progression Free Survival (PFS) is defined as the minimum time to death or any progression.
Patients will be followed up to 2 years
Metastasis free survival time
Tijdsspanne: Patients will be followed up to 2 years
Metastasis-free survival (MFS) is defined as the minimum time to development of metastases or death, whichever occurs first.
Patients will be followed up to 2 years
Incidence of intrahepatic failure
Tijdsspanne: Patients will be followed up to 2 years
Intrahepatic failure will include progression of the treated lesion(s) as well as development of other new liver lesions.
Patients will be followed up to 2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan Rogel Cancer Center

Onderzoekers

  • Hoofdonderzoeker: Dawn Owen, M.D., Ph.D., University of Michigan Rogel Cancer Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 mei 2017

Primaire voltooiing (Verwacht)

1 april 2022

Studie voltooiing (Verwacht)

1 april 2022

Studieregistratiedata

Eerst ingediend

17 mei 2017

Eerst ingediend dat voldeed aan de QC-criteria

24 mei 2017

Eerst geplaatst (Werkelijk)

30 mei 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

20 juni 2018

Laatst geverifieerd

1 juni 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UMCC 2017.001
  • HUM00124501 (Andere identificatie: University of Michigan)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Carcinoom, hepatocellulair

Klinische onderzoeken op Microwave Ablation (MWA)

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