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NCT Number: NCT06317324

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Xishan Hao, M.D.

PRINCIPAL_INVESTIGATOR

Zhao Yan

CONTACT

[email protected]

+86-22-23340123 ext. 5509

About this study

Main purpose:

Explore the survival differences between SBRT and surgery for NSCLC patients with interlobular pleural invasion.

Secondary purpose:

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Different treatments

Other

NSCLC patients receive the treatment of SBRT

Primary outcomes

  1. OS

    Time frame: 3 years

    Overall Survival

  2. PFS

    Time frame: 3 years

    Progression Free Survival

  3. MRFS

    Time frame: 3 years

    Distant Metatasis Free Survival

  4. LRFS

    Time frame: 3 years

    Local Relapse Free Survival

Secondary outcomes

  1. VC

    Time frame: 1 year

    Vital Capacity

  2. FVC

    Time frame: 1 year

    Forced Vital Capacity

  3. FEV1

    Time frame: 1 year

    Forced Expiratory Volume in one second

  4. DLCO

    Time frame: 1 year

    Diffusing Capacity of the lungs for carbon monoxide

  5. PFR

    Time frame: 1 year

    Pulmonary Function Report

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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