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

Surgery Clinical Trial

Official title:

A Prospective, Single Center, Observational Study:Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317324
• Other study ID #: bc2023200
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: March 2024
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC
• Radiotherapy
• Surgery

Intervention

Other:
• Different treatments
NSCLC patients receive the treatment of SBRT

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Overall Survival	3 years
Primary	PFS	Progression Free Survival	3 years
Primary	MRFS	Distant Metatasis Free Survival	3 years
Primary	LRFS	Local Relapse Free Survival	3 years
Secondary	VC	Vital Capacity	1 year
Secondary	FVC	Forced Vital Capacity	1 year
Secondary	FEV1	Forced Expiratory Volume in one second	1 year
Secondary	DLCO	Diffusing Capacity of the lungs for carbon monoxide	1 year
Secondary	PFR	Pulmonary Function Report	1 year