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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04527419
• Other study ID #: SLNDILA
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: February 9, 2027

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: Haoxuan Wu, Dr.
• Phone: 86-13901770461
• Email: haoxuanwu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 638
• Est. completion date: February 9, 2027
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Procedure:
• Systematically mediastinal lymph node dissection
Systematically mediastinal lymph node dissection will be performed.
• No mediastinal lymph node dissection
No mediastinal lymph node dissection will be performed.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Disease-free survival means the period after surgery when no disease can be detected.	3 years after the surgery
Secondary	Overall survival	Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.	3 years after the surgery
Secondary	Rate of patients with perioperative complications	The perioperative complication includes death, wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc.	1 month after the surgery
Secondary	Distribution of lymph node metastasis	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.	1 month after the surgery