Идёт набор NCT05914831

Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

Фаза II С лечением Breast Cancer Female

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: Ultra-fractionated WBI, Ultra-fractionated PBI.
Кому может быть актуально: Состояния в реестре: Breast Cancer Female. Базовые параметры: от 50 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: Сербия
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

Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial

Обзор

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions. The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Подробное описание

Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery.

If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy).

The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO).

A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment (for left breast radiation therapy, active breath control is used - in deep inspiration or respiratory gating).

Вмешательства

Лучевая терапия Ultra-fractionated WBI
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.
Лучевая терапия Ultra-fractionated PBI
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.

Первичные конечные точки

Acute toxicity [Срок оценки: 1-6 months after RT]
Late toxicity [Срок оценки: 6-60 months after RT]

Вторичные конечные точки (6)

Local-regional control [Срок оценки: 3, 5 and 10 years]
Disease-free survival [Срок оценки: 3, 5 and 10 years]
Overall Survival [Срок оценки: 3, 5 and 10 years]
Distant metastasis occurrence [Срок оценки: 3, 5 and 10 years]
Cosmetic outcome [Срок оценки: at baseline, during the radiotherapy, immediately after radiotherapy termination and then in the first 2 years every 3 months, in the 4th and 5th year every 6 months and after 5 years once per year.]
QoL assessment [Срок оценки: at baseline, during the radiotherapy, immediately after radiotherapy termination and then in the first 2 years every 3 months, in the 4th and 5th year every 6 months and after 5 years once per year.]

Критерии участия

Критерии включения

Breast-conserving surgery
Invasive ductal carcinoma
Age ≥ 50
Tumor size ≤ 3 cm
R0 resection
Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
Hormone receptor status - any
Histological grade G1 or G2