Clinical trial · Interventional
AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma
AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study
NCT07609355CI-TRIAL-00112716GLORIAnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ART | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention arm
- 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.
- interventionNames
- Radiation: ART
Primary outcomes (2)
- measure
- Proportion of patients successfully completing the full course of ART treatment
- timeFrame
- End of ART
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.