SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009)

Not Applicable

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Procedure: Systematically mediastinal lymph node dissection; Procedure: No mediastinal lymph node dissection

• Registration Number: NCT04527419
• Lead Sponsor: Fudan University

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 lung adenocarcinoma: a multi-center, prospective clinical trial

Detailed Description

Patients will be evaluated for inclusion criteria and exclusion criteria, and then they will sign informal consent if desired. He/she will be randomly assigned to the intervention according to a prepared random tables. Patients in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS).

The sample size was estimated with reference to our previous data, in which the 3-year DFS was 96.6% for patients diagnosed with cT1 ground glass opacity (GGO) dominated invasive lung adenocarcinoma and underwent SLND. We assumed that if 3-year DFS of patients in non-SLND group was over 91.6% , then we would deem the non-SLND group to be non-inferior to the SLND group. The sample size was estimated to be 638.

In order to render the number of recruited patients for each tumor location conform to the actual distribution, we designed a random table for each tumor location. In our previous study, for cT1 GGO dominated invasion lung adenocarcinoma, tumor in the left upper lobe, left lower lobe, right upper lobe, right middle lobe and right lower lobe accounted for 24.7%, 13.2%, 37.6%, 6.6% and 17.9%, respectively. Therefore, the random number table for left upper lobe, left lower lobe, right upper lobe, right middle lobe and right lower lobe included 158 patients, 84 patients, 240 patients, 42 patients and 114 patients, respectively. The total number of patients enrolled was designed to be 638.

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-26
• Study Start: 2022-02-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2024-02-09
• Study Completion: 2027-02-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 638

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.

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Exclusion Criteria

• Other than invasive adenocarcinoma by pathological analysis.
• Other than lobectomy or sublobar resection in surgical procedure.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systematically mediastinal lymph node dissection group	Systematically mediastinal lymph node dissection	Systematically mediastinal lymph node dissection will be performed.
No mediastinal lymph node dissection group	No mediastinal lymph node dissection	Mediastinal lymph node dissection will not be performed.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years after the surgery	Disease-free survival means the period after surgery when no disease can be detected.

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years after the surgery	Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.
Rate of patients with perioperative complications	1 month after the surgery	The perioperative complication includes death, wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc.
Distribution of lymph node metastasis	1 month after the surgery	The distribution of lymph node metastasis refers to the number of metastatic lymph nodes per station and the proportion of metastatic lymph nodes to harvested lymph nodes.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China