Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.

Tianjin Medical University

Status: Enrolling

Conditions: Surgery; Radiotherapy; NSCLC

Treatments: Other: Different treatments

Study type: Observational

Funder types: Other

Identifiers

NCT06317324

bc2023200

Details and patient eligibility

About

The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:

1. Explore the survival differences.
2. Explore of the lung function changes before and after different treatments.

Full description

Main purpose:

Explore the survival differences between SBRT and surgery for NSCLC patients with interlobular pleural invasion.

Secondary purpose:

1. Longitudinal exploration of the differences in heart and lung function changes before and after treatment between SBRT and surgery of NSCLC patients with interlobular pleural invasion
2. Longitudinal exploration of dynamic changes in lung lobe volume before and after treatment in NSCLC patients with interlobular pleural invasion treated with SBRT and surgical intervention.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Surgery Group

Description:

Diagnosed as primary lung cancer by imaging/pathology, meeting the indications for surgical treatment; The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology.

SBRT Group

Description:

Diagnosed as primary lung cancer by imaging/pathology, meeting the indications for SBRT treatment; The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology.

Treatment:

Other: Different treatments