Clinical trial NCT06317324: Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.
Official title: A Prospective, Single Center, Observational Study:Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Radiotherapy
Surgery
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinically diagnosed cIB-IIIB stage (cT2-3N0M0) NSCLC patients and tumor invades Interlobular pleura.

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.

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.

Primary outcomes:
measure: OS
timeFrame: 3 years
measure: PFS
timeFrame: 3 years
measure: MRFS
timeFrame: 3 years
measure: LRFS
timeFrame: 3 years
Secondary outcomes:
measure: VC
timeFrame: 1 year
measure: FVC
timeFrame: 1 year
measure: FEV1
timeFrame: 1 year
measure: DLCO
timeFrame: 1 year
measure: PFR
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
state: Tianjin
Study officials:
References: