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Completed

NCT Number: NCT06232967

PPIO-006 Primary Tumor Resection for IVa NSCLC

The goal of this mutli-center observational study is toinvestigate the impact of primary tumor resection (PTR) on the long-term survival of patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination (DPD). The main question it aims to answer is: whether primary tumor resection improve long-term survival of NSCLC patients with dry pleural dissemination.

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Key information

Conditions

Non-Small-Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China

About this study

Non-small-cell lung cancer (NSCLC) patients with dry pleural dissemination have poor survival rates and are generally contraindicated for surgery. Previous single-center retrospective studies have suggested that these patients may benefit from primary tumor resection (PTR). However, the evidence supporting PTR is still limited, especially in the era of targeted therapy. This study aimed to investigate the impact of PTR on the long-term survival of patients with NSCLC and DPD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) pathologically confirmed primary NSCLC with malignant pleural dissemination, (2) no preoperative treatment, (3) age 80 years or younger, (4) clinicopathologic data and follow-up results were complete.

Exclusion criteria

(1) pleural effusion, contralateral lung metastasis or distant metastasis revealed preoperatively, and (2) with a history of other malignant disease.

Treatment and study plan

Primary tumor resection or not

Procedure

For patients with non-small-cell lung cancer (NSCLC) and dry pleural dissemination, surgical decisions to perform exploratory thoracotomy only or primary tumor resection with wedge resection, segmentectomy, or lobectomy were based on surgeon experience and patient preference.

Primary outcomes

  1. Disease-specific survival (DSS)

    Time frame: Up to 8 years

    The duration from the day of surgery to the the last follow-up visit or to death specifically caused by NSCLC.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to 8 years

    The duration of survival with no evidence of progression of the disease.

Sponsors and collaborators

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other

Collaborators

  • First Affiliated Hospital of Chongqing Medical University

Registry information

Official study title

Long-term Outcome of Primary Tumor Resection in Non-Small-Cell Lung Cancer Patients With Dry Pleural Dissemination: A Multi-center Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Jun 27, 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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