PPIO-006 Primary Tumor Resection for IVa NSCLC

June 26, 2024 updated by: WEI GUO, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Army Medical Center of the People's Liberation Army

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

From January 2016 to December 2023, a total of 204 consecutive NSCLC patients with surgically confirmed DPD were collected retrospectively from three high-volume centers in China. Data were obtained by reviewing medical records.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary tumor resection (PTR group)
includes wedge resection, segmentectomy, or lobectomy.
Procedure: Primary tumor resection or not
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.
Exploratory thoracotomy (ET group)
JSimply open and close surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 8 years
The duration of survival with no evidence of progression of the disease.
Up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

First Affiliated Hospital of Chongqing Medical University

Investigators

  • Principal Investigator: Wei Guo, PhD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wei Guo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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