A multicenter, prospective clinical study to evaluate the efficacy and safety of stereotactic radiotherapy (SBRT) for patients with residual malignant pulmonary nodules after lung cancer surgery

Research background and project basis

Lung cancer is the most deadly malignancy in the world. In recent years, with the implementation of CT screening for lung cancer, more and more pulmonary nodules, especially multiple pulmonary nodules, have been found, and a small number of multiple pulmonary nodules have been pathologically confirmed as multiple primary malignant pulmonary nodules, that is, early multiple primary lung cancer. For these patients, surgery is the best treatment option, but some patients with multiple primary malignant pulmonary nodules cannot tolerate single or multiple operations to remove all tumor sites due to underlying disease, insufficient cardiopulmonary reserve function, or large number of nodules scattered.

Stereotactic Body Radiation Therapy (SBRT) relies on a precise computer design system, which can make the radiation concentrate in the tumor target area while the surrounding normal tissue is irradiated with a small dose, so as to achieve efficient killing of tumor while causing less damage to surrounding organs, and the incidence of postoperative complications is low. Studies have shown that the treatment of early lung cancer with SBR can achieve a local control rate (LCR) of about 80%, a 5-year overall survival (OS) of about 50%, and a grade 3 or higher complication rate of less than 10%. It is considered a safe and effective treatment for inoperable early stage lung cancer.

The purpose of this project is to evaluate the efficacy and safety of SBRT treatment for patients with residual malignant pulmonary nodules after lung cancer surgery, and analyze the recurrence and metastasis pattern and the blood markers to predict the efficacy and prognosis, aiming to provide a new treatment option for patients with residual malignant pulmonary nodules after lung cancer surgery who cannot tolerate multiple operations.

Research purpose

2.1 Main research objectives

The 2-year LCR and the incidence of treaty-related adverse events at all levels were collected in patients with residual malignant pulmonary nodules after lung cancer treated with SBRT to determine the efficacy and safety of SBRT in these patients.

2.2 Secondary research purposes

The 2-year local recurrence rate, 2-year regional recurrence rate, 2-year distant metastasis rate, 2-year PFS, 2-year OS and other indicators of postoperative residual malignant pulmonary nodules in patients with lung cancer treated with SBRT were collected to analyze the recurrence and metastasis pattern and prognosis of these patients.

2.3 Explore the purpose of the study

The distribution of blood markers of postoperative residual malignant pulmonary nodules in patients with lung cancer treated with SBRT was collected before treatment, at the end of treatment, and 1 month after treatment to explore the blood markers of efficacy and prognosis.