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

Launched by FANG WU · Nov 5, 2021

Keywords

ClinConnect Summary

The SMILE trial is looking at a new treatment called Stereotactic Body Radiotherapy (SBRT) for patients who have multiple lung nodules after having lung cancer surgery. This study aims to see how effective and safe SBRT is for patients who have leftover malignant nodules but are not able to undergo more surgery. The trial is currently recruiting participants aged 18 to 75 who have at least two lung nodules, with at least one confirmed as lung cancer. Participants should also be able to sign consent and swallow tablets.

If you join the trial, you can expect to receive SBRT, which is a type of radiation therapy that delivers high doses of radiation to targeted areas while minimizing damage to surrounding healthy tissue. This study seeks to provide a new option for those who cannot tolerate additional surgeries. It's important that eligible participants do not have any other serious health conditions or previous treatments that could interfere with the trial. Overall, this trial could help advance treatment options for patients with multiple lung nodules, and your participation might contribute to important findings in lung cancer care.

Gender

ALL

Eligibility criteria

• 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