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AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma (GLORIA)

19 mai 2026 mis à jour par: Chen Chunyan, Sun Yat-sen University

AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study

The goal of this clinical trial is to evaluate CBCT image-based triggered online adaptive radiotherapy (ART) and assess its clinical benefits in protecting organs at risk (OARs).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

25

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.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510060
        • Sun Yat-sen University Cancer Center
        • Contact:

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • ECOG Performance Status: 0 or 1, with no deterioration within the 2 weeks prior to enrollment.
  • Age: ≥18 years and ≤75 years.
  • Diagnosis & Stage: Pathologically confirmed primary gastric lymphoma, staged as I, II, or IIE according to the Lugano modified staging system.
  • Treatment Plan: Deemed by both medical oncology and radiation oncology physicians to be candidates for definitive radiotherapy or consolidative radiotherapy following chemotherapy, based on assessment prior to enrollment.
  • Adequate Organ Function (including Bone Marrow Function, Hepatic Function, Coagulation Function, Renal Function, Cardiac Function)
  • Informed Consent & Compliance: Voluntarily participate, provide written informed consent, and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Known history of malignancy (excluding patients with basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, carcinoma in situ, or papillary thyroid carcinoma who have undergone curative surgery).
  • Prior abdominal or pelvic radiotherapy within the past 3 years. Women who are pregnant or breastfeeding (women of childbearing potential must consider pregnancy testing; effective contraception must be emphasized during treatment).
  • Inability to undergo contrast-enhanced magnetic resonance imaging (MRI) due to factors such as allergy to MRI contrast agents or claustrophobia.
  • Any other disease or clinically significant laboratory abnormality, severe medical or psychiatric condition/disorder, or substance abuse (including alcohol abuse) considered by the investigator as potentially compromising patient safety, the integrity of the study, patient participation, or interfering with the study objectives and analysis of results.

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: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention arm
This study is a prospective, single-arm, phase II exploratory trial. The primary objectives are to preliminarily evaluate the feasibility and safety of AI-assisted adaptive radiation therapy (ART) for the treatment of gastric lymphoma patients and to explore its preliminary efficacy.
Radiation: ART
All participants will receive intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). To ensure study quality, all radiation therapy plans will undergo review by the research team at Sun Yat-sen University Cancer Center. Target volume delineation will adhere to the involved-site radiation therapy (ISRT) principles recommended by the International Lymphoma Radiation Oncology Group (ILROG) consensus guidelines. Treatment will be categorized based on intent: definitive radiation therapy or consolidative radiation therapy. The ART process primarily includes: imaging acquisition → AI-assisted automatic contouring → adaptive decision-making → plan optimization → verification → treatment delivery and documentation.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients successfully completing the full course of ART treatment
Délai: End of ART
Defined as the proportion of patients who complete ≥90% of the planned fractions of the online ART process. This includes successful completion of online image evaluation, plan modification (if required), verification that the modified plan meets preset criteria (OARs dose constraints, PTV coverage ≥95%), dose verification, and successful treatment delivery. Cases where treatment is not completed due to technical failures causing delays >60 minutes, or patient intolerance (e.g., vomiting/pain requiring interruption, or positional shifts >5mm that cannot be corrected) are excluded from this success metric.
End of ART
Objective Response Rate (ORR)
Délai: Imaging assessment at approximately 12 weeks (3months) after completion of radiotherapy
Defined as the sum of patients achieving Complete Response (CR) and Partial Response (PR) according to the 2014 Lugano Classification for response assessment, divided by the number of patients in the analysis set. That is, ORR = (CR + PR) / Number of patients in the analysis set. Response assessment is performed 3 months after the last fraction of radiotherapy, categorized as either radiographic response (assessed by CT/MRI) and/or metabolic response (assessed by PET/CT).
Imaging assessment at approximately 12 weeks (3months) after completion of radiotherapy

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
1-year Progression-Free Survival (PFS) Rate
Délai: At 12 months post-radiotherapy
PFS is defined as the time from the day of first study drug administration to tumor progression (in any aspect) or death (from any cause).
At 12 months post-radiotherapy
1-year Overall Survival (OS) Rate
Délai: At 12 months post-radiotherapy
OS is defined as the time from Day 1 of treatment to death from any cause.
At 12 months post-radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Délai: From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.

Throughout this study and during the follow-up period, the proportion of patients experiencing ≥Grade 2 radiotherapy-related toxicities (per CTCAE v5.0). Acute phase: From Day 1 of radiotherapy to 3 months post-treatment.

Late phase: From 3 months to 1 year post-radiotherapy. Late toxicities include but are not limited to gastrointestinal events (e.g., gastric ulcer, hemorrhage, stenosis), hepatic toxicity, or other organ toxicities.
From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.
Quality of Life (QoL)
Délai: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
The QoL was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), Version 3.0, which represent functions, symptoms, or health conditions. The EORTC QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
EORTC Quality of Life Questionnaire-Gastric Cancer Module
Délai: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
The QoL STO22 was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire-Gastric Cancer Module (QLQ-STO22). The EORTC QLQ-STO22: a quality of life instrument for use in international clinical trials in gastric cancer. A total of 22 items are included. Each item is graded from 1 to 4, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
Patient-Reported Quality of Life (PRO-QoL) Deterioration Rate
Délai: Baseline and 1 month post-radiotherapy
Defined as the assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQ-C30), from baseline to 1 month post-radiotherapy completion.
Baseline and 1 month post-radiotherapy
Average duration per online ART session (from CBCT start to beam-on)
Délai: Periprocedural of ART
Periprocedural of ART
Evaluation of actual target coverage throughout the entire treatment (assessed as the fraction of treatment sessions where PTV D95% ≥ 95% of the prescribed dose)
Délai: From the first treatment session through the end of ART, an average of 4 weeks
From the first treatment session through the end of ART, an average of 4 weeks

Collaborateurs et enquêteurs

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

Parrainer

Sun Yat-sen University

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 (Estimé)

8 mai 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

7 mai 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-FXY-065

Plan pour les données individuelles des participants (IPD)

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

NON

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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