A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.
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: Proton radiotherapy, Photon radiotherapy.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 80 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 Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.
Обзор
The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are: 1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery? 2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?
Вмешательства
- Лучевая терапия Proton radiotherapy
Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week. - Лучевая терапия Photon radiotherapy
Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week.
Первичные конечные точки
- The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years [Срок оценки: Until 2 years after radiotherapy]
Вторичные конечные точки (6)
- Late toxicities after 2 years of radiotherapy [Срок оценки: Until 5 years after radiotherapy]
- Locoregional recurrence (LRR) [Срок оценки: Until 5 years after treatment.]
- Disease-free survival (DFS) [Срок оценки: Until 5 years after treatment.]
- Overall survival (OS) [Срок оценки: Until 5 years after treatment.]
- uality of life, as measured by EORTC Quality of Life Questionnaires-B23 [Срок оценки: During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy]
- Cosmetic outcome [Срок оценки: Until 5 years after treatment.]
Критерии участия
Критерии включения
- Histologically confirmed invasive breast cancer.
- Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
- Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.
- Post mastectomy: Patients who have undergone mastectomy, with postoperative pathology staged as pT1-3 N1-3, excluding N3c, and who have had an implant (prosthesis or tissue expander) placed.
- Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
- No distant metastasis.
- Age range: 18-80 years.
- Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.
- Non-pregnant and non-lactating women.
- Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.
Критерии исключения
- Presence of Ductal Carcinoma In Situ (DCIS).
- Tumor staging: Patients presenting with T4, N0, or N3c disease.
- History of prior radiotherapy to the ipsilateral chest or breast.
- Surgical margin status: Margins are either positive or close, defined as:
Invasive carcinoma within 1 mm of the surgical margin.
- Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.
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
- Shanghai Proton and Heavy Ion Center — Шанхай
Идентификаторы
NCT: NCT06677879 · SPHIC-TR-BCa2024-01