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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06317324
Enrollment
150
Registered
2024-03-19
Start date
2023-08-01
Completion date
2026-08-01
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC, Radiotherapy, Surgery

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.

Interventions

OTHERDifferent treatments

NSCLC patients receive the treatment of SBRT

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
OS3 yearsOverall Survival
PFS3 yearsProgression Free Survival
MRFS3 yearsDistant Metatasis Free Survival
LRFS3 yearsLocal Relapse Free Survival

Secondary

MeasureTime frameDescription
VC1 yearVital Capacity
PFR1 yearPulmonary Function Report
FVC1 yearForced Vital Capacity
FEV11 yearForced Expiratory Volume in one second
DLCO1 yearDiffusing Capacity of the lungs for carbon monoxide

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026