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Идёт набор NCT03853733

Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer

— Наблюдательное Rectal 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: rectal cancer radiotherapy.
Кому может быть актуально
Состояния в реестре: Rectal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
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

Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study

Обзор

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Подробное описание

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis were considered eligible.

Patients were immobilized in the prone position with a belly-board in order to reduce small bowel irradiation. To limit organ motion patient were instructed to empty the bladder and drink 500cm3 of water 45-60 minutes before CT simulation and before every treatment fraction.

A conformal three-dimensional radiotherapy technique was planned to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.

Symptomatic response after the end of treatment has been measured for bleeding and pain and acute toxicity were reported according to CTCAEv4.0 scale.

Вмешательства

  • Лучевая терапия rectal cancer radiotherapy
    Conformal three-dimensional radiotherapy to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.

Первичные конечные точки

  • Symptomatic response after palliative radiotherapy (bleeding) [Срок оценки: two months afer the end of radiotherapy]
  • Symptomatic response after palliative radiotherapy (pain) [Срок оценки: two months afer the end of radiotherapy]
  • Gastrointestinal toxicity after the end of radiotherapy [Срок оценки: two months afer the end of radiotherapy]
  • Genitourinary toxicity after the end of radiotherapy [Срок оценки: two months afer the end of radiotherapy]
Вторичные конечные точки (1)
  • palliative colostomy after the end of palliative radiotherapy [Срок оценки: two months afer the end of radiotherapy]

Критерии участия

Критерии включения

  • Patients with rectal or sigmoidal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis
  • Patients with = or > 18 years old
  • Patients treated with a radiotherapy dose of 39Gy in 13 fractions of 3 Gy

Критерии исключения

  • Patients with a non rectum or sigma colo-rectal cancer.
  • Patients with <18 years old.
  • Patients treated with concurrent chemotherapy
  • Patients candidates for surgical resection after radiotherapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Consorci Sanitari de Terrassa — Terrassa

Публикации

  • EP-1648: Palliative hipofractionated radiotherapy in non operable rectal cancer: preliminary results RSS Download PDF J. Lozano Galan, E. Rubio and J. Solé Radiotherapy and Oncology, 2018-04-01, Volume 127, Pages S887-S887

Идентификаторы

NCT: NCT03853733 · ONCORTCST2019-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗