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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
• Intervention / Treatment: Radiation: ART

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Yan Chen, Prof.; Phone Number: 020-87342926; Email: chenchuny@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
      • Contact: Chun-Yan Chen, Prof.; Phone Number: 020-87342926; Email: chenchuny@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients successfully completing the full course of ART treatment	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year Progression-Free Survival (PFS) Rate	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	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	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)	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	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	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)		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)		From the first treatment session through the end of ART, an average of 4 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 8, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: AI; Exploratory; Online Adaptive Radiotherapy; Gastric Lymphoma
• Additional Relevant MeSH Terms: Familial primary gastric lymphoma
• Other Study ID Numbers: 2026-FXY-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No