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NCT Number: NCT05113017

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncology Department,Second Xiangya Hospital of Central South University, Changsha, Hunan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

NO Intervention

Primary outcomes

  1. Local control rate of cancer of SBRT

    Time frame: 2-year

    Local control rate of cancer

  2. Incidence of Treatment-Emergent Adverse Events of SBRT [Safety and Tolerability]

    Time frame: 2-year

    Treatment-related adverse event

Secondary outcomes

  1. Survival

    Time frame: 2-year

    Survival rate without local recurrence

  2. Survival

    Time frame: 2-year

    Survival rate without distant metastasis

  3. PFS

    Time frame: 2-year

    Progression-free survival rate

  4. OS

    Time frame: 2-year

    Overall survival rate

Study contacts

Contact information is provided by the study sponsor or research team.

Chunhong Hu, professor

CONTACT

[email protected]

+86 13508486908

Sponsors and collaborators

Lead sponsor

Fang Wu

Other

Collaborators

  • Hunan Cancer Hospital
  • The Third Xiangya Hospital of Central South University
  • Xiangya Hospital of Central South University

Registry information

Official study title

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)

Acronym: SMILE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2021
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.