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

NCT ID: NCT06317324

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-08-01

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.

Conditions

NSCLC; Radiotherapy; Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgery Group

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.

No interventions assigned to this group

SBRT Group

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.

Different treatments

Intervention Type: OTHER

NSCLC patients receive the treatment of SBRT

Interventions

Different treatments

NSCLC patients receive the treatment of SBRT

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhao Yan

Role: primary

yanzhaotj@126.com

+86-22-23340123 ext. 5509

Other Identifiers

bc2023200

Identifier Type: -

Identifier Source: org_study_id