PPIO-006 Primary Tumor Resection for IVa NSCLC

Completed

• Conditions: Non-small-cell Lung Cancer (NSCLC)
• Interventions: Procedure: Primary tumor resection or not

• Registration Number: NCT06232967
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

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 Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30
• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary tumor resection (PTR group)	Primary tumor resection or not	includes wedge resection, segmentectomy, or lobectomy.

Primary Outcome Measures

Name	Time	Method
Disease-specific survival (DSS)	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 Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 8 years	The duration of survival with no evidence of progression of the disease.

Trial Locations

Locations (1)

Army Medical Center of the People's Liberation Army; 🇨🇳 Chongqing, Chongqing, China