Selective lymph node dissection for early-stage lung cancer
Official title: Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial
Run by Fudan University · NCT06031246 · Data updated 2026-11-12
This study is testing if a specific type of surgery called selective lymph node dissection can help people with early-stage lung cancer live longer and stay cancer-free.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 634 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Please Select) |
| Status | Recruiting |
| Started | April 1, 2023 |
| Main results expected | January 1, 2026 |
| Study ends | December 31, 2030 |
| Registry record updated | September 11, 2023 |
| Trial ID | NCT06031246 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with resectable cT1N0M0 NSCLC located in the apical segment and a tumor-to-lung ratio greater than 0.5.
✕Probably not a fit
Patients with non-resectable tumors, those who have received prior lung cancer treatments, or those with specific types of lung adenocarcinoma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of selective lymph node dissection in patients with cT1N0M0 invasive non-small cell lung cancer (NSCLC) that has a tumor-to-lung ratio greater than 0.5 and is located in the apical segment. The study will assess the 5-year overall survival rates, as well as the rates of post-operative lymph node metastasis and recurrence-free survival. Participants will undergo the surgical procedure of selective lymph node dissection to determine its therapeutic benefits.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and reduce recurrence in patients with early-stage lung cancer.
How similar studies have gone: Other studies have shown promising results with selective lymph node dissection in similar patient populations, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who sign the informed consent form and are willing to complete the study according to the plan; 2. Aged from 18 to 80 years old; 3. ECOG equals 0 or 1; 4. Not receiving lung cancer surgery before; 5. Resectable peripheral cT1N0M0 tumors with CTR\>0.5 located in the apical segment; 6. Non-lepidic predominant invasive NSCLC dignosed by frozen section; 7. Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: 1. Not cT1N0M0; 2. Nodules not located in the apical segment or CTR≤0.5; 3. Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically; 4. Receiving lung cancer surgery before; 5. Receiving radiotherapy or chemotherapy.
Where it's running
-
Chaoqiang Deng
Shanghai, Please Select, China Recruiting
Study contacts
- Principal investigator: Haiquan Chen, M.D. — Fudan University
- Study coordinator: Chaoqiang Deng, M.D.
- Email: fdudengcq@163.com
- Phone: +86-13122677592
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.