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

Recruiting

• Conditions: NSCLC; Radiotherapy; Surgery
• Interventions: Other: Different treatments

• Registration Number: NCT06317324
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SBRT Group	Different treatments	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.

Primary Outcome Measures

Name	Time	Method
LRFS	3 years	Local Relapse Free Survival
PFS	3 years	Progression Free Survival
MRFS	3 years	Distant Metatasis Free Survival
OS	3 years	Overall Survival

Secondary Outcome Measures

Name	Time	Method
FVC	1 year	Forced Vital Capacity
PFR	1 year	Pulmonary Function Report
VC	1 year	Vital Capacity
FEV1	1 year	Forced Expiratory Volume in one second
DLCO	1 year	Diffusing Capacity of the lungs for carbon monoxide

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy; 🇨🇳 Tianjin, Tianjin, China