Actively Recruiting
Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and Diameter ≤ 2 cm: a Prospective, Single-arm, Multi-center Phase I Trial
Led by Fudan University · Updated on 2025-08-12
684
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of a selective lymph node dissection strategy in patients with invasive non-small cell lung cancer (NSCLC) who have tumors sized 2 cm or smaller with a consolidation-to-tumor ratio (CTR) between 0.5 and 1. The study focuses on a specific approach where lower mediastinal lymph nodes are not removed for tumors in the upper lung lobe, and upper mediastinal lymph nodes are not removed for tumors in the lower lung lobe. This trial seeks to better predict outcomes and reduce surgical trauma in early-stage NSCLC patients. Participants will undergo a selective lymph node dissection procedure based on tumor location, avoiding removal of certain lymph nodes depending on whether the tumor is in the upper or lower lobe. This approach is being studied in a prospective, single-arm, multicenter clinical trial. The study builds on prior research analyzing thousands of NSCLC cases to support this selective method. Patients will receive surgery without additional radiotherapy or chemotherapy as their primary treatment. During the study, participants will be followed for two years to monitor disease-free survival and overall survival after the surgery. Researchers will collect clinical and pathological data to assess the safety and effectiveness of the selective lymph node dissection strategy. Participants will have regular evaluations, including imaging and pathological confirmation, to track cancer status and any recurrence. The total participation duration includes the surgery and a two-year follow-up period.
CONDITIONS
Brief Title
Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and able to complete all trial procedures
- Age between 18 and 80 years at consent
- ECOG performance status of 0 or 1
- No previous lung cancer surgery
- Pathologically confirmed non-small cell lung cancer during or after surgery
- Single pulmonary nodule with mixed ground glass on CT or multiple nodules with main lesion as above
- Solid component proportion between 0.5 and 1, nodule size ≤ 2 cm
- Clinical stage T1N0M0 and surgically resectable
- No prior radiotherapy or chemotherapy for primary treatment
You will not qualify if you...
- Clinical stage other than 0.5 < CTR < 1 and diameter ≤ 2 cm for T1N0M0
- Unable to undergo complete surgical resection
- Lung malignancy other than non-small cell lung cancer by cytology or pathology
- Previous lung cancer surgery
- Prior radiotherapy or chemotherapy not as primary treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo selective lymph node dissection where lower mediastinal lymph nodes are not cleared for upper lobe tumors and upper mediastinal lymph nodes are not cleared for lower lobe tumors.
1 surgical visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety and efficacy of the selective lymph node dissection strategy.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
P
Penghao Deng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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