Comparing outcomes of SBRT and surgery for lung cancer patients with pleural invasion
A Prospective, Single Center, Observational Study:Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.
This study looks at whether stereotactic body radiotherapy or surgery is better for people with lung cancer that has spread to the pleura, by comparing survival rates and changes in lung and heart function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06317324 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the prognostic differences between stereotactic body radiotherapy (SBRT) and surgical intervention for patients with non-small cell lung cancer (NSCLC) exhibiting interlobular fissure invasion. The study will explore survival rates and assess changes in lung function and heart function before and after treatment. Additionally, it will longitudinally analyze changes in lung lobe volume in patients receiving either SBRT or surgery. The findings may provide insights into the most effective treatment options for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above diagnosed with primary NSCLC and interlobular pleural invasion, who meet specific clinical staging criteria.
Not a fit: Patients with small cell lung cancer, non-primary lung cancer, or those with distant metastasis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective treatment approach for NSCLC patients with interlobular fissure invasion, potentially improving survival and quality of life.
How similar studies have performed: While there have been studies comparing SBRT and surgery for lung cancer, the specific focus on interlobular fissure invasion makes this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily participate and sign an informed consent form in writing; 2. Age 18 and above, regardless of gender; 3. Diagnosed as primary lung cancer through imaging/pathology, meeting the indications for SBRT and surgical treatment; 4. The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology; 5. Imaging diagnosis of NSCLC patients with tumor invasion of interlobular pleura; 6. No serious abnormalities in the blood system, heart, lungs, liver, kidney function, or immune deficiency; 7. There are no restrictions on surgical methods, and both VATS and open chest surgery are acceptable; 8. Physical condition score ECOG level 0-2; 9. Expected survival time\>3 months. Exclusion Criteria: 1. Pathological confirmation of small cell lung cancer; 2. Non solitary lung cancer, non primary lung cancer, with distant metastasis; 3. Individuals with a history of severe lung or heart disease; 4. Severe comorbidities, such as uncontrolled hypertension, heart failure, etc; 5. Pregnant or lactating women; 6. Previous history of malignant tumors; 7. Refusal or inability to sign the informed consent form for participating in the trial.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy — Tianjin, Tianjin Municipality, China (Recruiting)
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.