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

NCT05113017 | Recruiting

• 1 other identifier: XYEYY20210728
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

The Efficacy and Safety of SBRT in MPLC

Keywords

SBRT, MPLC, Efficacy, Safety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Survival

  2-year

• Survival

  2-year

• PFS

  2-year

• OS

  2-year

Study Arms (1)

SBRT group

Patients with residual lung nodules are treated with SBRT

Other: NO Intervention

Interventions

NO Intervention OTHER

NO Intervention

SBRT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Fang Wu: lead
• Xiangya Hospital of Central South University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Hunan Cancer Hospital: collaborator

Study Sites (5)

Oncology Department，Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Hunan Cancer Hospital

Changsha, China

RECRUITING

The Third Xiangya Hospital, Central South University

Changsha, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Central Study Contacts

Chunhong Hu, professor

CONTACT

+86 13508486908; huchunh5829@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 9, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (5)