AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma

NCT07609355 | Not Yet Recruiting DMC

• 1 other identifier: 2026-FXY-065
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Keywords

AI; Online Adaptive Radiotherapy; Gastric Lymphoma; Exploratory

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 1-year Progression-Free Survival (PFS) Rate

  At 12 months post-radiotherapy

• 1-year Overall Survival (OS) Rate

  At 12 months post-radiotherapy

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.

• Quality of Life (QoL)

  Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy

• EORTC Quality of Life Questionnaire-Gastric Cancer Module

  Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Interventions

ART RADIATION

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Familial primary gastric lymphoma

Central Study Contacts

Chun-Yan Chen, Prof.

CONTACT

020-87342926; chenchuny@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 27, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)