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Radiothérapie avec des protons ou des photons dans le traitement des patients atteints d'un cancer du foie

9 octobre 2026 mis à jour par: NRG Oncology

Un essai randomisé de phase III comparant les protons aux photons pour le carcinome hépatocellulaire

This phase III trial studies how well radiation therapy with protons works compared with photons in treating patients with liver cancer. Radiation therapy, such as photon therapy, uses high energy x-rays to send the radiation inside the body to the tumor while proton therapy uses a beam of proton particles. Proton therapy can stop shortly after penetrating through the tumor and may cause less damage to the surrounding healthy organs and result in better survival in patients with liver cancer.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

I. To determine if overall survival (OS) is different for hepatocellular carcinoma patients treated with protons compared to photons.

SECONDARY OBJECTIVES:

I. To determine the difference in progression-free-survival (PFS) in patients with hepatocellular carcinoma (HCC) treated with protons compared to patients with HCC treated with photons.

II. To determine the difference in local progression (LP) in patients with HCC treated with protons compared to patients with HCC treated with photons.

III. To determine differences in toxicity in patients with HCC treated with protons versus photons.

IV. To determine differences in fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue in patients with HCC treated with protons, versus photons; as well as quality-adjusted survival, if the primary endpoint is met.

V. To determine if there are correlations between the baseline values of hepatocyte growth factor (HGF) and outcomes (OS/PFS/fatigue).

EXPLORATORY OBJECTIVES:

I. To determine differences in overall quality of life, measured by Functional Assessment of Cancer Therapy-Hepatobiliary Cancer (FACT-Hep) in patients with HCC treated with protons.

II. Biospecimen collection for future correlative science projects.

OUTLINE: Patients are randomized to 1 of 2 arms, photon or proton therapy (see Arms and Interventions).

Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.

Type d'étude

Interventionnel

Inscription (Réel)

116

Phase

  • Phase 3

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
    • Georgia
      • Atlanta, Georgia, États-Unis, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, États-Unis, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, États-Unis, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, États-Unis, 30308
        • Emory Proton Therapy Center
    • Illinois
      • Warrenville, Illinois, États-Unis, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, États-Unis, 21201
        • Maryland Proton Treatment Center
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Dearborn, Michigan, États-Unis, 48124
        • Corewell Health Dearborn Hospital
      • Royal Oak, Michigan, États-Unis, 48073
        • Corewell Health William Beaumont University Hospital
      • Troy, Michigan, États-Unis, 48085
        • Corewell Health Beaumont Troy Hospital
    • Missouri
      • St Louis, Missouri, États-Unis, 63110
        • Washington University School of Medicine
    • New Jersey
      • Basking Ridge, New Jersey, États-Unis, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, États-Unis, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, États-Unis, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, États-Unis, 11725
        • Memorial Sloan Kettering Commack
      • East White Plains, New York, États-Unis, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, États-Unis, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, États-Unis, 10035
        • New York Proton Center
      • Uniondale, New York, États-Unis, 11553
        • Memorial Sloan Kettering Nassau
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cleveland, Ohio, États-Unis, 44106
        • Case Western Reserve University
      • Columbus, Ohio, États-Unis, 43210
        • Ohio State University Comprehensive Cancer Center
      • West Chester, Ohio, États-Unis, 45069
        • University of Cincinnati Cancer Center-West Chester
    • Texas
      • Houston, Texas, États-Unis, 77030
        • UT MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, États-Unis, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, États-Unis, 98109
        • Fred Hutchinson 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:

  • Pathologically (histologically or cytologically) or radiographically-proven (based on the American Association for the Study of Liver Diseases [AALSD] criteria) unresectable or locally recurrent hepatocellular cancer prior to registration

  • Appropriate stage for study entry based on the following diagnostic workup:

    • All patients must have computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan prior to registration; if CT contrast is contraindicated, CT chest without contrast and magnetic resonance imaging (MRI) of abdomen is permitted
    • Participants must have measurable disease at study entry, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 2 cm with conventional techniques or as > 1 cm with spiral CT scan
    • Patient must have 3 or fewer single or multinodular tumors; for patients with a single lesion, lesion must be 15 cm or less in greatest dimension; for patients with two lesions, no lesion may be greater than 10 cm in greatest dimension; for patients with three lesions, no lesion may be greater than 6 cm in greatest dimension; portal vein involvement or thrombosis combined with a single lesion that is >= 1 cm and =< 15 cm in greatest dimension is allowed

  • Age >= 18

  • Zubrod performance status 0-1 within 30 days prior to registration

  • Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry

  • Absolute neutrophil count (ANC) >= 1,000 cells/mm^3

  • Platelets >= 50,000 cells/mm^3

  • Hemoglobin >= 9.0 g/dl; (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)

  • Total bilirubin < 4 x institutional upper limit of normal (ULN)

  • Transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) < 6 x institutional ULN

  • Albumin >= 2.5 g/dl

  • Creatinine < 2 mg/dl

  • Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable

  • Must have Child-Turcotte-Pugh (CTP) A or B7

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study registration

Exclusion Criteria:

  • PRIOR TO STEP ONE REGISTRATION:
  • Definitive clinical or radiologic documentation of extrahepatic tumor, defined as extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm
  • Uncontrolled prior invasive malignancy, excluding the current diagnosis
  • Systemic chemotherapy for the study cancer < 2 weeks prior to registration
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • HIV positive with CD4 count < 200 cells/microliter; note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 (cluster of differentiation 4)count >= 200 cells/microliter prior to registration; note also that HIV testing is not required for eligibility for this protocol; this exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (to include Y90)
  • Prior liver transplant
  • PRIOR TO STEP TWO RANDOMIZATION:
  • Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment

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: Proton Therapy (Arm 1)

Proton therapy delivered in 5 fractions over 15 days or 15 fractions over 24 days, determined by the treating physician.
Radiation: Proton Therapy

Fractions

Autres noms:
  • Radiothérapie du cancer
  • ENERGY_TYPE
  • Irradier
  • Irradié
  • Irradiation
  • Radiation
  • Radiothérapie, SAI
  • Radiothérapie
  • RT
  • Thérapie, Radiation
  • Type d'énergie
Expérimental: Photon Therapy (Arm 2)

Photon therapy delivered in 5 fractions over 15 days or 15 fractions over 24 days, determined by the treating physician.
Radiation: Photon Therapy

Fractions

Autres noms:
  • Radiothérapie du cancer
  • ENERGY_TYPE
  • Irradier
  • Irradié
  • Irradiation
  • Radiation
  • Radiothérapie, SAI
  • Radiothérapie
  • RT
  • Thérapie, Radiation
  • Type d'énergie

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Alive (Overall Survival)
Délai: From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months. One- and two-year estimates are reported.

Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at last known follow-up.
From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months. One- and two-year estimates are reported.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Alive Without Progression (Progression-free Survival)
Délai: From randomization to progression, death, or last follow-up, whichever occurs first. Median follow-up time for all patients at time of analysis was 20.4 months. One- and two-year estimates are reported.

Progression is defined as local, regional, or distant progression. Progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive without progression at time of last follow-up.
From randomization to progression, death, or last follow-up, whichever occurs first. Median follow-up time for all patients at time of analysis was 20.4 months. One- and two-year estimates are reported.
Percentage of Participants With Local Progression
Délai: From randomization to local progression, death, or last follow-up, whichever occurs first. Median follow-up time for all patients at time of analysis was 20.4 months. One- and two-year estimates are reported.

Local progression rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive without local failure are censored at last known follow-up.
From randomization to local progression, death, or last follow-up, whichever occurs first. Median follow-up time for all patients at time of analysis was 20.4 months. One- and two-year estimates are reported.
Percentage of Participants With Grade 3+ Treatment-Related Adverse Events
Délai: From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months.

Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events.
From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months.
Change From Baseline to One Month in the Patient Reported Outcomes Measurement Information System - Fatigue Short Form version1.0 8a [PROMIS Fatigue Score]
Délai: Baseline and one month

The PROMIS Fatigue Short Form v1.0 8a contains 8 items that assess self-reported fatigue symptoms over the past 7 days. Item responses are summed to obtain a raw score ranging from 8 to 40, which is then converted to a standardized T-score (mean = 50, standard deviation = 10). Higher T-scores indicate greater fatigue. Change from baseline is calculated as the post-baseline T-score minus the baseline T-score, with positive change scores indicating increased fatigue and negative change scores indicating decreased fatigue.
Baseline and one month
Quality-adjusted LIfe Years
Délai: Baseline up to 12 months

Was to be calculated using the EuroQol 5-Dimension Three Level Questionnaire (EQ-5D-3L).
Baseline up to 12 months
Percentage of Participants Alive (Overall Survival) by Plasma Hepatocyte Growth Factor (HGF) Level
Délai: From randomization to death or last follow-up. One- and two-year estimates will be reported.

Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at last known follow-up. HGF will be dichotomized at 2311 pg/mL.
From randomization to death or last follow-up. One- and two-year estimates will be reported.
Percentage of Participants Alive Without Progression (Progression-free Survival) by HGF Level
Délai: From randomization to progression, death, or last follow-up, whichever occurs first. One- and two-year estimates will be reported.

Progression is defined as local, regional, or distant progression. Progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive without progression at time of last follow-up. HGF will be dichotomized at 2311 pg/mL.
From randomization to progression, death, or last follow-up, whichever occurs first. One- and two-year estimates will be reported.
Change From Baseline to One Month in PROMIS Fatigue Score by HGF Level
Délai: Baseline and one month

The PROMIS Fatigue Short Form v1.0 8a contains 8 items that assess self-reported fatigue symptoms over the past 7 days. Item responses are summed to obtain a raw score ranging from 8 to 40, which is then converted to a standardized T-score (mean = 50, standard deviation = 10). Higher T-scores indicate greater fatigue. Change from baseline is calculated as the post-baseline T-score minus the baseline T-score, with positive change scores indicating increased fatigue and negative change scores indicating decreased fatigue. HGF will be dichotomized at 2311 pg/mL.
Baseline and one month

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Overall Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Version 4
Délai: Baseline up to 12 months

Differences between treatment arms in the overall score, the four domains (physical, social, emotional, and functional well-being), and the additional concerns subscale will also be analyzed.
Baseline up to 12 months
Title: Percentage of Participants Alive (Overall Survival) by Sex
Délai: From randomization to death or last follow-up. Median follow-up for all patients at time of analysis was 20.4 months. Two-year estimates are reported.

NIH-required analysis. Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
From randomization to death or last follow-up. Median follow-up for all patients at time of analysis was 20.4 months. Two-year estimates are reported.
Percentage of Participants Alive (Overall Survival) by Race
Délai: From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months. Two-year estimates are reported.

NIH-required analysis. Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months. Two-year estimates are reported.
Percentage of Participants Alive (Overall Survival) by Ethnicity
Délai: From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months. Two-year estimates are reported.

NIH-required analysis. Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
From randomization to death or last follow-up. Median follow-up time for all patients at time of analysis was 20.4 months. Two-year estimates are reported.

Collaborateurs et enquêteurs

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

Parrainer

NRG Oncology

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Theodore S Hong, NRG Oncology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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)

26 janvier 2018

Achèvement primaire (Réel)

20 janvier 2026

Achèvement de l'étude (Estimé)

20 janvier 2031

Dates d'inscription aux études

Première soumission

12 juin 2017

Première soumission répondant aux critères de contrôle qualité

12 juin 2017

Première publication (Réel)

14 juin 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NRG-GI003
  • U10CA180868 (Subvention/contrat des NIH des États-Unis)
  • NRG-GI003 (Autre identifiant: CTEP)
  • NCI-2016-02009 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • NRG-GI003 (Autre identifiant: NRG Oncology)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

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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