Selective lymph node dissection for early-stage lung cancer
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
PHASE3 · Fudan University · NCT06031246
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 634 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Please Select) |
| Trial ID | NCT06031246 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with selective lymph node dissection in similar patient populations, indicating potential for success.
Eligibility criteria
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 this trial is running
Shanghai, Please Select
- 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
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.
Conditions: Lung Adenocarcinoma, Lymph Node Metastasis