NCT07609355尚未招募不适用
AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年5月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Chen Chunyan
Clinical Professor
Sun Yat-sen University
研究点 (1)
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