Intensity Modulated Radiotherapy for Breast Cancer (IMRT)
8 августа 2017 г. обновлено: Washington University School of Medicine
Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast.
These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).
Обзор исследования
Подробное описание
IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several different angles and strengths to deliver precise doses to the regions at risk for recurrence of breast cancer while reducing or sparing the dose to critical structures (heart, lungs) and nearby normal tissue.
Тип исследования
Интервенционный
Регистрация (Действительный)
100
Фаза
- Фаза 1
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63110
- Washington University School of Medicine
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
Inclusion Criteria:
- Female gender
- Age ≥ 18 years
- Invasive primary female breast cancer
- Pathologically proven regional nodal metastasis
- Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.
- Signed study specific consent form
Exclusion Criteria:
- Distant metastasis
- Currently Pregnant
- Psychiatric or addictive disorders that preclude informed consent
- Time from initial diagnosis to the start of radiation therapy > one year
- Estimated life expectancy judged to be < one year
- Prior radiation to the ipsilateral breast or chest wall
- Primary breast cancer is lymphoma or sarcoma
- Patients being treated with concurrent chemotherapy.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: IMRT
The prescribed dose for all patients will be 5040 cGy in 28 fractions.
Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
Временное ограничение: Within 1 year of protocol registration
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The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes:
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Within 1 year of protocol registration
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Evaluate the rate and severity of both acute and late cutaneous toxicity
Временное ограничение: 6-8 months following completion of treatment and 12-14 months following completion of treatment
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6-8 months following completion of treatment and 12-14 months following completion of treatment
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Evaluate the rate and severity of late subcutaneous fibrosis
Временное ограничение: 6-8 months following completion of treatment and 12-14 months following completion of treatment
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6-8 months following completion of treatment and 12-14 months following completion of treatment
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Evaluate the rate of radiation pneumonitis
Временное ограничение: 6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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Evaluate ipsilateral upper quadrant function
Временное ограничение: Pretreatment and 3-4 months following completion of treatment
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For patients who receive physical therapy, objective measures of the rotator cuff, bursa, and joint space will be evaluated by diagnostic ultrasound if medically indicated.
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Pretreatment and 3-4 months following completion of treatment
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Evaluate patient quality of life
Временное ограничение: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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Evaluate local-regional control rates
Временное ограничение: 12-14 months following completion of radiation therapy
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12-14 months following completion of radiation therapy
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Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification
Временное ограничение: 12-14 months following completion of treatment
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12-14 months following completion of treatment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Imran Zoberi, MD, Washington University School of Medicine
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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- Cho BC, Hurkmans CW, Damen EM, Zijp LJ, Mijnheer BJ. Intensity modulated versus non-intensity modulated radiotherapy in the treatment of the left breast and upper internal mammary lymph node chain: a comparative planning study. Radiother Oncol. 2002 Feb;62(2):127-36. doi: 10.1016/s0167-8140(01)00472-8.
- Welsh JS, Patel RR, Ritter MA, Harari PM, Mackie TR, Mehta MP. Helical tomotherapy: an innovative technology and approach to radiation therapy. Technol Cancer Res Treat. 2002 Aug;1(4):311-6. doi: 10.1177/153303460200100413.
- Ruchala KJ, Olivera GH, Kapatoes JM, Schloesser EA, Reckwerdt PJ, Mackie TR. Megavoltage CT image reconstruction during tomotherapy treatments. Phys Med Biol. 2000 Dec;45(12):3545-62. doi: 10.1088/0031-9155/45/12/303.
- Ding GX, Duggan DM, Coffey CW. Characteristics of kilovoltage x-ray beams used for cone-beam computed tomography in radiation therapy. Phys Med Biol. 2007 Mar 21;52(6):1595-615. doi: 10.1088/0031-9155/52/6/004. Epub 2007 Feb 27.
- Huntzinger C, Munro P, Johnson S, Miettinen M, Zankowski C, Ahlstrom G, Glettig R, Filliberti R, Kaissl W, Kamber M, Amstutz M, Bouchet L, Klebanov D, Mostafavi H, Stark R. Dynamic targeting image-guided radiotherapy. Med Dosim. 2006 Summer;31(2):113-25. doi: 10.1016/j.meddos.2005.12.014.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
4 января 2008 г.
Первичное завершение (Действительный)
8 августа 2016 г.
Завершение исследования (Действительный)
8 августа 2016 г.
Даты регистрации исследования
Первый отправленный
4 января 2008 г.
Впервые представлено, что соответствует критериям контроля качества
14 января 2008 г.
Первый опубликованный (Оценивать)
15 января 2008 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 августа 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 августа 2017 г.
Последняя проверка
1 августа 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 07-1077 / 201106403
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования IMRT
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Cancer Institute and Hospital, Chinese Academy...НеизвестныйМелкоклеточный рак легкогоКитай
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National Cancer Institute, EgyptАктивный, не рекрутирующий
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Sun Yat-sen UniversityАктивный, не рекрутирующийКачество жизни | Смертность | Новообразования носоглотки | ОсложненияКитай
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Royal Marsden NHS Foundation TrustЗавершенный
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University of Michigan Rogel Cancer CenterПрекращеноРак молочной железыСоединенные Штаты
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Washington University School of MedicineПрекращеноРак головы и шеиСоединенные Штаты
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Alberta Health servicesЗавершенныйНовообразования щитовидной железы
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St. Jude Children's Research HospitalMayo ClinicПрекращеноБрюшная нейробластомаСоединенные Штаты
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Fujian Cancer HospitalЕще не набираютНазофарингеальная карцинома
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Jiangxi Provincial Cancer HospitalSixth Affiliated Hospital, Sun Yat-sen UniversityЕще не набирают