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

20 juin 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Retiré

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • The University of Michigan Comprehensive Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: MWA
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
Radiation: Microwave Ablation (MWA)
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
Expérimental: SBRT
SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.
Radiation: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time to local tumor progression
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of gastrointestinal (GI) and hepatobiliary toxicity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan Rogel Cancer Center

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 mai 2017

Achèvement primaire (Anticipé)

1 avril 2022

Achèvement de l'étude (Anticipé)

1 avril 2022

Dates d'inscription aux études

Première soumission

17 mai 2017

Première soumission répondant aux critères de contrôle qualité

24 mai 2017

Première publication (Réel)

30 mai 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juin 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juin 2018

Dernière vérification

1 juin 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • UMCC 2017.001
  • HUM00124501 (Autre identifiant: University of Michigan)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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