Not yet recruiting NCT07609355
AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ART.
- Who it may be relevant to
- Registry conditions: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study
Overview
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).
Interventions
- 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: definit
Primary outcome measures
- Proportion of patients successfully completing the full course of ART treatment [Time frame: End of ART]
- Objective Response Rate (ORR) [Time frame: Imaging assessment at approximately 12 weeks (3months) after completion of radiotherapy]
Secondary outcome measures (8)
- 1-year Progression-Free Survival (PFS) Rate [Time frame: At 12 months post-radiotherapy]
- 1-year Overall Survival (OS) Rate [Time frame: At 12 months post-radiotherapy]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.]
- Quality of Life (QoL) [Time frame: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy]
- EORTC Quality of Life Questionnaire-Gastric Cancer Module [Time frame: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy]
- Patient-Reported Quality of Life (PRO-QoL) Deterioration Rate [Time frame: Baseline and 1 month post-radiotherapy]
- Average duration per online ART session (from CBCT start to beam-on) [Time frame: 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) [Time frame: From the first treatment session through the end of ART, an average of 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07609355 · 2026-FXY-065