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

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.

Study Overview

• Status: Recruiting
• Conditions: The Efficacy and Safety of SBRT in MPLC
• Intervention / Treatment: Other: NO Intervention

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Chunhong Hu, professor; Phone Number: +86 13508486908; Email: huchunh5829@126.com

Study Locations

• China
  • Changsha, China
    • Recruiting
    • Hunan Cancer Hospital
    • Contact: Huai Liu
  • Changsha, China
    • Recruiting
    • Xiangya Hospital, Central South University
    • Contact: Yingying Zhang
  • Changsha, China
    • Recruiting
    • The Third Xiangya Hospital, Central South University
    • Contact: Xuewen Liu
  • Wuhan, China
    • Recruiting
    • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Contact: Liu Huang
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • Oncology Department，Second Xiangya Hospital of Central South University
      • Contact: Chunhong Hu, professor; Phone Number: +86 13508486908; Email: huchunh5829@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with inoperable residual malignant nodules after early multiple primary lung cancer surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SBRT group; Patients with residual lung nodules are treated with SBRT	Other: NO Intervention; NO Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control rate of cancer of SBRT	Local control rate of cancer	2-year
Incidence of Treatment-Emergent Adverse Events of SBRT [Safety and Tolerability]	Treatment-related adverse event	2-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival rate without local recurrence	2-year
Survival	Survival rate without distant metastasis	2-year
PFS	Progression-free survival rate	2-year
OS	Overall survival rate	2-year

Collaborators and Investigators

• Sponsor: Fang Wu
• Collaborators: Xiangya Hospital of Central South University; Hunan Cancer Hospital; The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: SBRT, MPLC, Efficacy, Safety
• Other Study ID Numbers: XYEYY20210728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No