Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Conditions
Keywords
AI, Online Adaptive Radiotherapy, Gastric Lymphoma, Exploratory
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).
Interventions
RADIATIONART
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients successfully completing the full course of ART treatment | 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. |
| Objective Response Rate (ORR) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Progression-Free Survival (PFS) Rate | 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). |
| 1-year Overall Survival (OS) Rate | At 12 months post-radiotherapy | OS is defined as the time from Day 1 of treatment to death from any cause. |
| 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. | 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. |
| Quality of Life (QoL) | 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. |
| EORTC Quality of Life Questionnaire-Gastric Cancer Module | 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. |
| Patient-Reported Quality of Life (PRO-QoL) Deterioration Rate | 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. |
| 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 | — |
Countries
China
Contacts
CONTACTChun-Yan Chen, Prof.
Outcome results
None listed