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Идёт набор NCT07401615

Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions

— Наблюдательное Non Small Cell Lung Cancer Pulmonary Stereotactic Radiotherapy

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Non Small Cell Lung Cancer, Pulmonary Stereotactic Radiotherapy. 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
Италия
Следующий шаг
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Официальное название

Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions: an Italian Multicenter Retrospective Analysis (STRILL IT)

Обзор

Radiotherapy (radiation treatment) is often used to treat lung cancers and lung tumors that have spread from other cancers. It can be very effective, especially in early-stage lung cancer or when there are only a few tumor sites. Even so, some patients later develop a local recurrence, meaning the cancer comes back in the same area that was previously treated with radiation. When this happens, treatment options are limited. Surgery can sometimes remove the recurrent tumor, but many patients are not able to have surgery because of their general health or because the tumor is difficult to remove. For these patients, a second course of radiotherapy (called re-irradiation) may be the only possible treatment. One type of radiotherapy, called stereotactic body radiotherapy (SBRT), delivers very high doses of radiation very precisely. SBRT has been used successfully as a second treatment after standard radiotherapy in some patients. However, there is very little information about using SBRT again in patients who already received SBRT the first time. Because only small studies have been done and the patients were very different from each other, doctors still do not know enough about how safe and effective a second SBRT treatment is. In particular, it is still unclear whether giving another high-dose radiation treatment is possible without causing serious side effects. More research is needed to better understand this option and help guide treatment decisions for patients.

Первичные конечные точки

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: from treatment to 1 years follow up]
Вторичные конечные точки (5)
  • Number of partecipant with local control [Срок оценки: from enrollment to 1 years follow up]
  • Time to new systemic treatment [Срок оценки: from enrollment to 1 years follow up]
  • Progression free survival [Срок оценки: from enrollment to 1 years follow up]
  • Overall survival [Срок оценки: from enrollment to 1 years follow up]
  • Dosimetric parameters related to treatment toxicity [Срок оценки: from enrollment to 1 years follow up]

Критерии участия

Критерии включения

  • Inoperable primary non-small cell lung cancer or other metastatic primaries with lung metastases, already treated with radical dose SBRT
  • Inoperable local recurrence (defined as a tumor recurrence overlapping the 50% isodose field) confirmed by documented radiographic findings and/or pathological biopsies within the thoracic area
  • Patients had previously received curative intent SBRT with a biologically equivalent dose equal or higher than 75 Gy
  • Stereotactic reirradiation with ablative purposes up to 8 fractions
  • No active distant metastasis or controlled distant metastasis at the time of re-irradiation
  • More than 12 months from previous SBRT
  • PS ≤ 2

Критерии исключения

  • Previous conventional RT
  • Reirradiation with palliative doses
  • Reirradiation with conventionally fractionated or mildly hypofractionated RT

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 11 центров
  • AST Papa Giovanni XXIII — Bergamo
  • Radiotherapy Department, Ospedale Bellaria Carlo Alberto Pizzardi — Bologna
  • REM Radioterapia — Catania
  • Radiation oncology unit, Ospedale San Raffaele — Milan
  • Radiotherapy Department, Istituto Europeo di Oncologia — Milan
  • IRCCS Humanitas Research Hospital — Rozzano
  • Radiotherapy Department, IRCCS Istituto Nazionale Fondazione G. Pascale — Naples
  • Centro Fondazione Policlinico Universitario "A. Gemelli", Radioterapia Oncologica — Roma
  • … и ещё 3 центра

Идентификаторы

NCT: NCT07401615 · STRILL IT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗