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

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Surgery; Radiotherapy
• Intervention / Treatment: Other: 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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
      • Contact: Zhao Yan; Phone Number: 5509 +86-22-23340123; Email: yanzhaotj@126.com
      • Principal Investigator: Xishan Hao, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Clinically diagnosed cIB-IIIB stage (cT2-3N0M0) NSCLC patients and tumor invades Interlobular pleura.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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.	Other: Different treatments; NSCLC patients receive the treatment of SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	3 years
PFS	Progression Free Survival	3 years
MRFS	Distant Metatasis Free Survival	3 years
LRFS	Local Relapse Free Survival	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: bc2023200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No