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Набор скоро начнётся NCT07609355

AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma

Без фазы С лечением Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ART.
Кому может быть актуально
Состояния в реестре: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT). Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study

Обзор

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).

Вмешательства

  • Лучевая терапия 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

Первичные конечные точки

  • Proportion of patients successfully completing the full course of ART treatment [Срок оценки: End of ART]
  • Objective Response Rate (ORR) [Срок оценки: Imaging assessment at approximately 12 weeks (3months) after completion of radiotherapy]
Вторичные конечные точки (8)
  • 1-year Progression-Free Survival (PFS) Rate [Срок оценки: At 12 months post-radiotherapy]
  • 1-year Overall Survival (OS) Rate [Срок оценки: At 12 months post-radiotherapy]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.]
  • Quality of Life (QoL) [Срок оценки: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy]
  • EORTC Quality of Life Questionnaire-Gastric Cancer Module [Срок оценки: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy]
  • Patient-Reported Quality of Life (PRO-QoL) Deterioration Rate [Срок оценки: Baseline and 1 month post-radiotherapy]
  • Average duration per online ART session (from CBCT start to beam-on) [Срок оценки: 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) [Срок оценки: From the first treatment session through the end of ART, an average of 4 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07609355 · 2026-FXY-065

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗