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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Treatments: Radiation: ART

Study type: Interventional

Funder types: Other

Identifiers

NCT07609355

2026-FXY-065

Details and patient eligibility

About

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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Intervention arm

Experimental group

Description:

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.

Treatment:

Radiation: ART