Идёт набор NCT06960707

Two Versus One Week Breast Radiotherapy (RT)

Фаза III С лечением 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: Radiation therapy - 1 week, Radiation therapy - 2 weeks.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: Без ограничений · 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)

Обзор

This study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. One group will receive radiation over one week (based on the FAST-FORWARD trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). The study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. It also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.

Подробное описание

Radiotherapy: one week (Arm 1) 2600 cGy in 5 fractions whole breast radiotherapy over one week versus 2 weeks (Arm 2), 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost.

Hypothesis: A regimen of whole breast radiotherapy to 2600 in five fractions, the current UK standard for early breast cancer (Arm 2), is not inferior to 3200cGy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 1), in terms of acute toxicity and long-term fibrosis, breast cosmesis and local control at 2 and 5 years. It will also test the hypothesis of superior local control at 10 years in Arm 2 compared to Arm 1.

Вмешательства

Лучевая терапия Radiation therapy - 1 week
2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week
Лучевая терапия Radiation therapy - 2 weeks
3200 cGy whole breast radiotherapy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 2) over 2 weeks. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost.

Первичные конечные точки

Rate of RT-related acute toxicity [Срок оценки: 1 month]

Вторичные конечные точки (7)

The long-term evaluations at 2 years of fibrosis based on LENT/SOMA [Срок оценки: 24 months]
The long-term evaluations at 2 years of breast cosmesis [Срок оценки: 24 months]
The long-term evaluations at 2 years of local control [Срок оценки: 24 months]
The long-term evaluations at 5 years OF fibrosis based on LENT/SOMA [Срок оценки: 60 months]
The long-term evaluations at 5 years of breast cosmesis [Срок оценки: 60 months]
The long-term evaluations at 5 years of local control. [Срок оценки: 60 months]
Superior local control at 10 years [Срок оценки: 120 months]

Критерии участия

Критерии включения

Women status post segmental mastectomy.
If unilateral, pT1-2 breast cancer excised with negative margins.
If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.
Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
Women with previous contralateral treated breast cancer can be enrolled in the trial.