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The Effectiveness and Safety of SBRT in the Treatment of Patients With MPLC After Surgery (SMILE)

The Effectiveness and Safety of SBRT in the Treatment of Patients With MPLC After Surgery (SMILE)

Recruiting
18-75 years
All
Phase N/A

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Overview

To prospectively evaluate the effectiveness and safety of SBRT in the treatment of residual malignant pulmonary nodules after lung cancer, and is committed to providing new treatment options for patients with multiple primary malignant pulmonary nodules who cannot tolerate multiple operations.

Eligibility

Inclusion Criteria:

        (1) Age 18-75 years old; (2) ECOG score 0-2 points; (3) Chest CT showed at least two lung
        nodules (pure ground glass, partial solid or solid nodules); (4) At least one lesion has
        been pathologically diagnosed as lung cancer (T1N0M0-T1N1M0); (5) At least one residual
        pulmonary nodule has been diagnosed pathologically or multidisciplinary diagnosis and
        treatment (MDT) discussed and considered as a primary malignant pulmonary nodule; (6) The
        residual lung nodules are inoperable or operable but the patient refuses to be surgically
        removed; (7) Have self-consciousness and can sign informed consent; (8) Must be able to
        swallow tablets.
        Exclusion Criteria:
        (1) There are metastatic pulmonary nodules; (2) Have received chest radiotherapy in the
        past; (3) Lymph node metastasis or distant metastasis; (4) The tumor is located in the
        proximal bronchial tree area. The proximal bronchial tree is defined as carina, left and
        right main bronchus, left and right upper lobe bronchus, middle bronchus, right middle lobe
        bronchus, lingual bronchus, left and right lower lobe bronchi; the proximal bronchial tree
        area is defined as surrounding the proximal bronchial tree in all directions The area
        within 2cm above; (5) Pneumonectomy patients; (6) Severe primary diseases such as heart,
        liver, kidney, hematopoietic system, etc.; (7) Women during pregnancy and lactation; (8)
        Active period of the human immunodeficiency virus (HIV) infection; (9) Those with active
        systemic infection, pneumonia, tuberculosis, and pericarditis; (10) There is a history of
        psychotropic drug abuse or drug abuse;(11)Insulin dependent diabetes;(12) Thyroid disease

Study details
    The Efficacy and Safety of SBRT in MPLC

NCT05113017

Fang Wu

29 January 2024

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