Clinical trial NCT04527419: SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009)
Official title: Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: invasive lung adenocarcinoma; systematically mediastinal lymph node dissection; ground-glass nodule
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random tables have been respectively developed according to tumor locaiton, which includes right-upper lobe, right-middle lobe, right-lower lobe, left-upper lobe and left-lower lobe. Prior to surgery, patients enrolled in the study will be assigned to treatment groups according to the order of the random tables.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years after the surgery
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years after the surgery
measure: Rate of patients with perioperative complications
timeFrame: 1 month after the surgery
measure: Distribution of lymph node metastasis
timeFrame: 1 month after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Shanghai Cancer Center
name: Haiquan Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: