Clinical trial NCT05113017: The Effectiveness and Safety of SBRT in the Treatment of Patients With MPLC After Surgery (SMILE)
Official 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: The Efficacy and Safety of SBRT in MPLC
Keywords: SBRT, MPLC, Efficacy, Safety
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
name: The Third Xiangya Hospital of Central South University
name: Hunan Cancer Hospital
First posted: 2021-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inoperable residual malignant nodules after early multiple primary lung cancer surgery

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.


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

Primary outcomes:
measure: Local control rate of cancer of SBRT
timeFrame: 2-year
measure: Incidence of Treatment-Emergent Adverse Events of SBRT [Safety and Tolerability]
timeFrame: 2-year
Secondary outcomes:
measure: Survival
timeFrame: 2-year
measure: Survival
timeFrame: 2-year
measure: PFS
timeFrame: 2-year
measure: OS
timeFrame: 2-year
Other outcomes:
Locations:
city: Changsha
country: China
facility: Oncology Department，Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: