Status:
RECRUITING
SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009)
Lead Sponsor:
Fudan University
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a study from Eastern Cooperative Thoracic Oncology Project, numbered as ECTOP-1009. Systematically mediastinal lymph node dissection or not in clinical stage T1 ground-glass dominated invasive...
Detailed Description
Following interim analysis of 302 patients revealed no lymph node metastasis in either study arm and 100% 2-year disease-free survival in both arms. The selective non-mediastinal lymph node dissection...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 9 2027
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT04527419
Start Date
February 9 2022
End Date
February 9 2027
Last Update
August 26 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China