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NCT05113017Recruiting

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

To Evaluate the Effectiveness and Safety of Stereotactic Radiotherapy (SBRT) in the Treatment of Patients With Residual Malignant Pulmonary Nodules After Lung Cancer Surgery: A Multi-center, Prospective Clinical Trial (SMILE)

Source: ClinicalTrials.gov · Last updated 28 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
5 Nov 2021
Start date
Jul 2021
Primary completion date
Dec 2026
Lead sponsor
Fang Wu
Diseases
Lung cancer
NCT number
NCT05113017

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From Jul 2021 to the primary completion date, Dec 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • (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

Who the study is looking for

  • (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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hunan Cancer Hospital
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ChangshaChinaRecruiting
Oncology Department,Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
Xiangya Hospital Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
The Third Xiangya Hospital, Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.