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Идёт набор NCT06686459

A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery

Без фазы С лечением Breast Cancer Invasive

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: ALL-in-one radiotherapy, IMRT.
Кому может быть актуально
Состояния в реестре: Breast Cancer Invasive. Базовые параметры: 18 лет — 70 лет · Женщины.
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

A Single-center Prospective Phase II Clinical Study With a Non-blind, Single-arm Design Combined With a Parallel External Control Group to Evaluate the Efficacy and Safety of Artificial Intelligence-assisted One-stop Radiotherapy After Breast-conserving Surgery

Обзор

Background: Breast cancer became the most prevalent cancer globally in 2020, and post-surgery radiotherapy is crucial for most patients. Traditional radiotherapy is complex and time-consuming, affecting patient experience. To streamline this, an AI-assisted All-in-one (AIO) radiotherapy approach has been developed, integrating steps like target delineation and planning to reduce wait times and enhance accuracy. Preliminary results are promising, with significant time savings and high pass rates in initial assessments. Further exploration is needed to confirm the accuracy, effectiveness, and safety of AIO radiotherapy. Primary objective: To conduct a prospective phase II clinical trial to determine the feasibility (including efficacy and safety) of AIO radiotherapy, and to provide a basis for establishing standard operating procedures. Secondary objectives: To assess the impact of AIO radiotherapy on overall survival, local regional recurrence, and distant metastasis rates. To investigate the incidence and contributing factors of cardiac damage after AIO radiotherapy.

Вмешательства

  • Лучевая терапия ALL-in-one radiotherapy
    ALL-in-one radiotherapy (breast + supraclavicular + internal mammary lymph node drainage area)
  • Лучевая терапия IMRT
    IMRT (breast + supraclavicular + internal mammary lymph node drainage area)

Первичные конечные точки

  • incidence rate of adverse effects [Срок оценки: 12 months after the end of radiotherapy]
Вторичные конечные точки (2)
  • overall survical [Срок оценки: measured from baseline through study completion, an average of 1 year]
  • disease free survival [Срок оценки: measured from baseline through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 1\. Female patients aged 18-70 years. 2. ECOG performance status of 0-2. 3. Newly diagnosed invasive breast cancer, underwent breast-conserving surgery plus axillary lymph node dissection, with positive axillary lymph nodes (ypN+) and negative surgical margins.

4\. No distant metastasis. 5. Capable of tolerating radiotherapy. 6. For ER/PR-positive patients, willing to receive anticipated 5 years of endocrine therapy.

7\. For HER2-positive patients, willing to receive anticipated 1 year of anti-HER2 targeted therapy.

8\. For patients requiring neoadjuvant/adjuvant chemotherapy, must have completed chemotherapy.

9\. Left ventricular ejection fraction (LVEF) measured by echocardiography is 50%.

10\. Must undergo adjuvant IMRT (Intensity-Modulated Radiation Therapy). 11. Capable of tolerating lying still on the treatment accelerator bed for 30 minutes to complete All-In-One radiotherapy.

12\. Have follow-up conditions and are willing to adhere to follow-up. 13. Signed an informed consent form.

Критерии исключения

  • 1\. Synchronous bilateral breast cancer; sentinel lymph node biopsy of the axilla was performed without axillary lymph node dissection.

2\. Stage I breast reconstruction surgery or expander implantation surgery on the affected side chest wall.

3\. The purpose of radiotherapy is palliative. 4. Myocardial infarction within the last 3 months or uncorrected unstable arrhythmia or uncorrected unstable angina.

5\. History of chest wall or supraclavicular radiotherapy in the past; past or concurrent second primary malignant tumors (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, and carcinoma in situ of the cervix).

6\. All-in-one one-stop radiotherapy has not been completed.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT06686459 · SL-B2024-438-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗