Comparing two surgical approaches for early-stage lung cancer with ground-glass nodules
Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage IA Non-small Cell Lung Cancer Presented as Ground-glass Nodules: Study Protocol of a Phase III, Randomized, Multi-center Trial (MELDSIG) in China
This study is testing which of two surgical methods is better for people with early-stage lung cancer that has ground-glass nodules, to see which one helps them live longer and stay cancer-free.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1362 (estimated) |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT04631770 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of mediastinal lymph node dissection versus spared mediastinal lymph node dissection in patients with stage I non-small cell lung cancer (NSCLC) characterized by ground-glass nodules. It is a prospective, multicenter, randomized trial involving 1,362 patients, with an enrollment period of three years followed by a five-year observation period. The study aims to compare overall survival and disease-free survival rates between the two surgical approaches, focusing on the unique characteristics of ground-glass nodules that may influence treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with clinical stage IA non-small cell lung cancer who have a single ground-glass nodule and no lymph node metastasis.
Not a fit: Patients with a history of other malignancies, active infections, or severe pulmonary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored surgical approaches for patients with early-stage lung cancer, potentially improving survival rates and reducing unnecessary procedures.
How similar studies have performed: While there have been studies on surgical approaches for lung cancer, this specific comparison of mediastinal lymph node dissection techniques in the context of ground-glass nodules is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis; * Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery; * No history of malignancies within past 5 years or lung surgery; * No anti-cancer treatment prior to surgery. Exclusion Criteria: * Simultaneous or metachronous (within the past 5 years) double cancers; * Active bacterial or fungous infection; * Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema; * Systemic steroidal medication; * Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.
Where this trial is running
Tianjin, Tianjin Municipality
- Ethics review board of Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhenfa Zhenfa, MD — Tianjin Medical University Cancer Institute and Hospital
- Study coordinator: Zhenfa Zhang, MD
- Email: zhangzhenfa1973@163.com
- Phone: +862223340123
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.