Evaluating lymph node dissection in early-stage lung adenocarcinoma
Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial
This study is testing whether skipping lymph node surgery can still help people with early-stage lung cancer live longer without their disease coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 545 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04527419 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the necessity of systematically mediastinal lymph node dissection (SLND) in patients with clinical stage T1 ground-glass dominated invasive lung adenocarcinoma. Participants will be randomly assigned to either receive SLND or not, with the primary endpoint being the 3-year disease-free survival (DFS). The study aims to determine if the non-SLND group can achieve a DFS rate comparable to the SLND group, based on previous data suggesting high survival rates. A total of 638 patients will be recruited across multiple centers to ensure a robust analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a single ground-glass nodule diagnosed as clinical stage T1N0M0 and planned for curative surgery.
Not a fit: Patients with other types of lung cancer, prior thoracic surgeries, or those who have received previous treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help refine surgical approaches for early-stage lung adenocarcinoma, potentially reducing unnecessary procedures.
How similar studies have performed: Previous studies have indicated high disease-free survival rates in similar patient populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical stage T1N0M0 and planned curative surgery. * A single lesion detected on computed tomography (CT) scan featured as ground glass nodule(GGO) and C/T ratio ≤0.5. * Age 18 to 75. * Patients who have signed the informed consent form. Exclusion Criteria: * Other than invasive adenocarcinoma by pathological analysis. * Patients undergoing wedge resection but not meeting the specific conditions of a Consolidation/Tumor Ratio (CTR) ≤ 0.25 AND a maximum tumor diameter ≤ 2 cm, based on the oncological outcomes of the JCOG0804/WJOG4507L trial. * Not complete resected or curative intent. * Patients who have history of other malignant tumors. * Patients who have history of thoracic surgery. * Patients who have received radiation, chemotherapy or other treatments previously.
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Haiquan Chen, Ph.D — Shanghai Cancer Center
- Study coordinator: Haoxuan Wu, Dr.
- Email: haoxuanwu@hotmail.com
- Phone: 86-13901770461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.