PPIO-006 Primary Tumor Resection for IVa NSCLC

NCT06232967 | Completed

• 1 other identifier: Wei Guo
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small-cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Disease-specific survival (DSS)

  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 Outcomes (1)

• Progression-free survival (PFS)

  Up to 8 years

Study Arms (2)

Primary tumor resection (PTR group)

includes wedge resection, segmentectomy, or lobectomy.

Procedure: Primary tumor resection or not

Exploratory thoracotomy (ET group)

JSimply open and close surgery.

Interventions

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 tumor resection (PTR group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

• Bao T, Deng Y, Chen L, Sun W, Ge M, Zhao X, Chen X, Zhang L, Wang Y, He X, Pu X, He Y, Yu J, Guo W. Primary tumour resection in non-small cell lung cancer patients with pleural dissemination unexpectedly detected during operation: a two-centre retrospective cohort study. BMC Cancer. 2025 Feb 21;25(1):316. doi: 10.1186/s12885-025-13747-3.

  PMID: 39984876 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Officials

• Wei Guo, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 31, 2024
• Study Start: April 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)