Идёт набор NCT06615466

Super-Hypofractionated Partial Breast Irradiation

Без фазы С лечением Breast Cancer Radiotherapy Side Effect

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: Partial Breast Irradiation.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Radiotherapy Side Effect. Базовые параметры: 45 лет — 74 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

Super-Hypofractionated Partial Breast Irradiation After Breast-Conserving Surgery for Early-Stage Low-Risk Breast Cancer: a Prospective, Single-arm Trial

Обзор

Partial breast irradiation is currently a hot topic in clinical research, but the appropriate population and appropriate irradiation The technology and dose fractionation mode are still inconclusive. Foreign studies have mostly selected patients with low risk of recurrence. Breast-conserving surgeries for early-stage breast cancer are increasing year by year in China. It is necessary to conduct prospective clinical studies to explore the Chinese population suitable for partial breast irradiation and the appropriate radiotherapy dose fractionation model. A preliminary study in our center has compared the safety and efficacy of a 2-week schedule of partial breast irradiation (40Gy/10f) and a 3-week schedule of whole-breast radiotherapy (43.5Gy/15f) in patients with early-stage low-risk breast cancer after breast-conserving surgery. , preliminary results show that the 2-week partial breast irradiation regimen is safe and effective. This study plans to continue to select low-risk breast-conserving patients, use extracorporeal intensity-modulated radiotherapy technology, refer to the radiotherapy dose fractionation model of the FAST-Forward study, and give partial breast irradiation 5.2 Gy/f/d, a total of 5 times, with a total dose of 26Gy, to further shorten the time The radiotherapy time is 1 week, and the acute and late adverse reactions of radiotherapy and the local control of the tumor are prospectively observed. Provide evidence for conducting a national multi-center phase III clinical randomized study.

Вмешательства

Лучевая терапия Partial Breast Irradiation
26Gy/5.2Gy/5f

Первичные конечные точки

Incidence of acute adverse reactions [Срок оценки: up to 6 months]

Вторичные конечные точки (2)

Incidence of late adverse reactions [Срок оценки: through study completion, an average of 5 year]
Survival [Срок оценки: through study completion, an average of 5 year]

Критерии участия

Критерии включения

≥45 years old, <75 years old women
Life expectancy >5 years
Start radiotherapy within 12 weeks after breast-conserving surgery (or within 8 weeks from the end of chemotherapy)
Invasive ductal carcinoma grade 1-2, or mucinous carcinoma, papillary carcinoma, canalicular carcinoma, medullary carcinoma; primary tumor

≤3.0cm; both pN0 (axillary dissection or sentinel lymph node biopsy)

Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required or pN0
Single focus (with MRI diagnosis)
Vascular tumor thrombus negative
ER and/or PR positivity (defined as strong positivity in >1% of tumor cell nuclei)
Negative pathological margin≥2mm
Place metal markers on the tumor bed
Sign the informed consent form