The Effectiveness and Safety of SBRT in the Treatment of... | NCT05113017

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

NCT05113017

Sponsor

Fang Wu

Status

Recruiting

Last Update Posted

Nov 28, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

The Efficacy and Safety of SBRT in MPLC

Interventions

NO Intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 5, 2021

First Submission Date that Met QC Criteria

Nov 5, 2021

First Posted Date

Nov 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2025

Last Update Posted Date

Nov 28, 2025Actual

Name	Class
Xiangya Hospital of Central South University	OTHER
The Third Xiangya Hospital of Central South University	OTHER
Hunan Cancer Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
SBRT group		Patients with residual lung nodules are treated with SBRT	Other: NO Intervention

Name	Type	Description	Arm Group Labels	Other Names
NO Intervention	Other	NO Intervention	SBRT group

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Survival	Survival rate without local recurrence	2-year
Survival	Survival rate without distant metastasis	2-year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample