Идёт набор NCT07164885

RAPART in Locally Advanced Non-small Cell Lung Cancer Patients

Без фазы С лечением Locally Advanced Non-small Cell Lung 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: Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）, Conventional radiotherapy.
Кому может быть актуально: Состояния в реестре: Locally Advanced Non-small Cell Lung 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: Китай
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

Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients

Обзор

This is a Phase II/III randomized clinical trial of Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) in locally advanced non-small cell lung cancer patients. The main objective is to test the overall improvement of overall survival (OS), progression free survival (PFS), and local progression free survival (LPFS) of unresectable stage III NSCLC under standard and non-standard mixed treatment conditions compared to conventional 60Gy radiotherapy.

Вмешательства

Лучевая терапия Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）
RAPART technology is a special combination of ART and RAPRT, with a total course limit of no more than 30 exposures. The entire course of treatment can be divided into two stages: the first stage is completely the same as the conventional radiotherapy group, with a total of 23 doses of 2 Gy per session. The second stage is the combination of ART and PAPRT. ART uses a CT or PET/CT localization simulation to be performed again during the course of treatment (usually after completing the first part
Лучевая терапия Conventional radiotherapy
conventional radiotherapy

Первичные конечные точки

overall survival [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

Вторичные конечные точки (2)

progression-free survival [Срок оценки: From enrollment to 3 years after the end of treatment]
Toxic events [Срок оценки: From enrollment to 3 years after treatment]

Критерии участия

Критерии включения

Adult research participants, aged over 18 years old;
Non small cell lung cancer that requires pathological confirmation;
All stage 3 unresectable non-small cell lung cancer, including stage correction after MDT and stage downgrading after treatment (4 → 3), and stage upregulation due to disease progression (2 → 3);
ECOG physical condition is 0-2;
In addition to study participants who have not received any treatment, study participants who have undergone surgery, chemotherapy, immunotherapy, and targeted therapy are also eligible for enrollment.