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

NCT06317324 | Recruiting

• 1 other identifier: bc2023200
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Explore the survival differences.
2. 2.Explore of the lung function changes before and after different treatments.

Conditions

NSCLC; Radiotherapy; Surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• VC

  1 year

• FVC

  1 year

• FEV1

  1 year

• DLCO

  1 year

• PFR

  1 year

Study Arms (2)

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

Interventions

Different treatments OTHER

NSCLC patients receive the treatment of SBRT

SBRT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Voluntarily participate and sign an informed consent form in writing;
• Age 18 and above, regardless of gender;
• Diagnosed as primary lung cancer through imaging/pathology, meeting the indications for SBRT and surgical treatment;
• The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology;
• Imaging diagnosis of NSCLC patients with tumor invasion of interlobular pleura;
• No serious abnormalities in the blood system, heart, lungs, liver, kidney function, or immune deficiency;
• There are no restrictions on surgical methods, and both VATS and open chest surgery are acceptable;
• Physical condition score ECOG level 0-2;
• Expected survival time\>3 months.

You may not qualify if:

• Pathological confirmation of small cell lung cancer;
• Non solitary lung cancer, non primary lung cancer, with distant metastasis;
• Individuals with a history of severe lung or heart disease;
• Severe comorbidities, such as uncontrolled hypertension, heart failure, etc;
• Pregnant or lactating women;
• Previous history of malignant tumors;
• Refusal or inability to sign the informed consent form for participating in the trial.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 19, 2024
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (1)