Идёт набор NCT04371913

Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study

Без фазы 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: 600cGY x 5 fractions APBI, 270cGy x 15 fractions WBRT.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: 19 лет — 90 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: США
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

Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study

Обзор

The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins. An additional goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with inbreast recurrences after a previous lumpectomy and PBI, the investigators propose to test whole breast RT (WBRT) with the target as the whole breast volume.

Подробное описание

Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for Radiation Therapy (RT) naïve patients at New York Presbyterian using EBRT or with the fractionation of 4050 cGy in 15 fractions over 3 weeks, based on the previous treatment that they received.

The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Вмешательства

Лучевая терапия 600cGY x 5 fractions APBI
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using EBRT
Лучевая терапия 270cGy x 15 fractions WBRT
Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)

Первичные конечные точки

Rate of treatment related adverse events as graded by CTCAE version 5.0 [Срок оценки: up to 1 year from completion of radiation treatment]

Вторичные конечные точки (12)

Number of participants with late toxicity will be measured as graded by CTCAE version 5.0 [Срок оценки: up to 60 months]
Change in number of participants with skin changes [Срок оценки: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.]
Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS) [Срок оценки: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.]
Number of participants who demonstrate local control [Срок оценки: 60 months]
Disease free survival (DFS) will be measured [Срок оценки: 60 months]
Overall Survival (OS) will be measured. [Срок оценки: 60 months]
Number of participants who received subsequent mastectomy in the treated breast [Срок оценки: 6 months]
Number of participants who received subsequent mastectomy in the treated breast [Срок оценки: 12 months]
Number of participants who received subsequent mastectomy in the treated breast [Срок оценки: 24 months]
Number of participants who received subsequent mastectomy in the treated breast [Срок оценки: 36 months]
Number of participants who received subsequent mastectomy in the treated breast [Срок оценки: 48 months]
Number of participants who received subsequent mastectomy in the treated breast [Срок оценки: 60 months]

Критерии участия

Критерии включения

Isolated ipsilateral unifocal breast lesions
Limited size (< 2-3 cm) without evidence of skin involvement
Histologically proven invasive breast carcinoma or carcinoma in situ
Negative histologic margins of resection
Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
No synchronous distant metastases
Age ≥ 18 years
≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
Previous WBI or IORT, brachytherapy or external beam partial breast treatment
Technical feasibility
Every kind of systemic therapy is allowed
Informed consent for clinical and research purposes signed