The Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy

Официальное название

Exploration of and Model Establishment of the Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy

Обзор

Definitive radiotherapy is one of the important methods for inoperable locally advanced lung cancer. The recommended dose for definitive radiotherapy is 60-70Gy, and the optimal dose is still uncertain. Residual lesion after radiotherapy is a risk factor for recurrence. High doses to targeted tumor areas can effectively improve the local control rate, while minimizing toxic side effects. The regression pattern of primary lesions in lung caner after radiotherapy has not been clarified. This study intends to retrospectively collect clinical data of lung cancer patients with definitive radiotherapy, and explore the pattern of tumor regression after radiotherapy. It will help optimize the radiotherapy plan for lung cancer, so as to improve the efficacy and prognosis.

Подробное описание

This study intends to retrospectively screen and include participants according to inclusion and exclusion criteria, and collect the clinical data of participants by previous medical records. Imaging tools will be used to quantify changes in the spatial location, diameter and volume of target lesions to evaluate tumor regression rate and radiotherapy efficacy, and to explore tumor regression pattern and establish model. In addition, the relationship between tumor regression rate, incidence of adverse radiation events, prognosis and related factors will be analysed.

Первичные конечные точки

• Tumor regression rate [Срок оценки: Within 1 year after completion of radiotherapy.]

Вторичные конечные точки (5)

• Objective response rate [Срок оценки: Within 1 year after completion of radiotherapy.]
• Disease control rate [Срок оценки: Within 1 year after completion of radiotherapy.]
• Progression-free survival [Срок оценки: From the start of treatment until the time of disease progression or death, assessed up to 120 months.]
• Overall survival [Срок оценки: From the start of treatment until the time of death, assessed up to 120 months.]
• Adverse event rate [Срок оценки: Within 1 year after completion of radiotherapy.]

Критерии участия

Критерии включения

• Age ≥18 years old;
• Stage II-III lung cancer with a clear pathological diagnosis report or medical record, not undergoing surgery before radiotherapy;
• The primary lung lesion received definitive radiotherapy (defined as conventional fractionation radiotherapy with dose ≥50Gy, stereotactic radiotherapy with biologically effective dose ≥100Gy);
• The target lesion of the lung receiving radiotherapy can be measured;
• Imaging data can be obtained before and after radiotherapy;
• Complete radiotherapy as planned, or the actual received dose has reached the defined definitive dose.

Exclusion Criteria：

• Before radiotherapy, the primary lesion of the lung had received local treatment such as surgery or ablative treatment;
• The radiotherapy plan was not completed, and the actual dose received did not reach the definitive dose (defined as conventional fractionation radiotherapy with dose <50Gy, stereotactic radiotherapy with biologically effective dose <100Gy)；
• Required imaging data cannot be obtained;
• Other conditions considered by the investigator to be inappropriate for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 2 центра

• China-Japan Friendship Hospital — Пекин
• Renmin Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT06692972 · 2024-ZF-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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