PPIO-006 Primary Tumor Resection for IVa NSCLC

Non-small-cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06232967
• Other study ID #: Wei Guo
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer (NSCLC)

Intervention

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.

Locations

Country	Name	City	State
China	Army Medical Center of the People's Liberation Army	Chongqing	Chongqing

Sponsors (3)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	First Affiliated Hospital of Chongqing Medical University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival (PFS)	The duration of survival with no evidence of progression of the disease.	Up to 8 years