Evaluating lymph node dissection in early-stage lung adenocarcinoma

Is this trial a fit for you?

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 investigates the necessity of systematically mediastinal lymph node dissection (SLND) in patients with clinical stage T1 ground-glass dominated invasive lung adenocarcinoma. Participants will be randomly assigned to either receive SLND or not, with the primary endpoint being the 3-year disease-free survival (DFS). The study aims to determine if the non-SLND group can achieve a DFS rate comparable to the SLND group, based on previous data suggesting high survival rates. A total of 638 patients will be recruited across multiple centers to ensure a robust analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Haiquan Chen, Ph.D — Shanghai Cancer Center
• Study coordinator: Haoxuan Wu, Dr.
• Email: haoxuanwu@hotmail.com
• Phone: 86-13901770461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.