Evaluating SBRT for treating lung nodules after surgery
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)
This study is testing if Stereotactic Body Radiation Therapy (SBRT) can safely help people with leftover lung nodules after surgery when more surgery isn't possible.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 5 sites (Changsha, Hunan and 4 other locations) |
| Trial ID | NCT05113017 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness and safety of Stereotactic Body Radiation Therapy (SBRT) in patients with multiple primary malignant pulmonary nodules following surgery. It focuses on individuals who have residual lung nodules that are either inoperable or for whom surgery is not an option. The study will involve a prospective evaluation of these patients to provide insights into new treatment alternatives for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with at least two lung nodules, one of which is pathologically diagnosed as lung cancer, and who cannot undergo surgery.
Not a fit: Patients with metastatic pulmonary nodules or those who have previously received chest radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-surgical treatment option for patients with multiple lung nodules, potentially improving their outcomes and quality of life.
How similar studies have performed: While this approach is being evaluated, similar studies using SBRT for lung cancer treatment have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha, Hunan and 4 other locations
- Oncology Department，Second Xiangya Hospital of Central South University — Changsha, Hunan, 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)
Study contacts
- Study coordinator: Chunhong Hu, professor
- Email: huchunh5829@126.com
- Phone: +86 13508486908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.