Primary Tumor Resection for M1a Stage Lung Cancer

Recruiting

• Conditions: Surgical Resection; Lung Cancer Metastatic

• Registration Number: NCT06547710
• Lead Sponsor: Fudan University

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
2. Aged 18-80 years (including critical values) when signing the informed consent form;
3. ECOG score 0 or 1;
4. No previous lung cancer surgery;
5. Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
6. Occult pleural metastasis found during surgery;
7. Preoperative lymph node staging is cN0;
8. First-time treatment and no radiotherapy or chemotherapy.

Exclusion Criteria

1. The lesion cannot be completely removed surgically;
2. Cytological or histological pathology confirms other lung malignancies other than lung cancer;
3. Patients who have undergone lung cancer surgery before;
4. Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median overall survival	About 10months.	Median overall survival for M1a patients underging surgery.

Secondary Outcome Measures

Name	Time	Method
2-year overall survival	2 years	2-year overall survival
5-year overall survival	5 years	5-year overall survival
FEV1 and FVC	0.5 year	Preoperative lung function test

Trial Locations

Locations (1)

Fudan University Cancer Center; 🇨🇳 Shanghai, Shanghai, China