SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma

• ClinicalTrials.gov Identifier: NCT04527419
• Recruitment Status: Not yet recruiting
• First Posted: August 26, 2020
• Last Update Posted: October 11, 2021
• Sponsor: Fudan University
• Information provided by (Responsible Party): Haiquan Chen, Fudan University

Study Description

Brief Summary:

Systematically mediastinal lymph node dissection or not in clinical stage T1 ground-glass dominated invasive lung adenocarcinoma: a multi-center, prospective clinical trial

Condition or disease	Intervention/treatment	Phase
Carcinoma, Non-Small-Cell Lung	Procedure: Systematically mediastinal lymph node dissection; Procedure: No systematically mediastinal lymph node dissection	Not Applicable

Detailed Description:

Patients who signed informal consent would be evaluated for inclusion criteria and exclusion criteria. He/she would then enter one group of the study according to a random number table. The patients in SLND group would receive systematically mediastinal lymph node dissection (SLND), while those in non-SLND group would not receive systematically mediastinal lymph node dissection. Finally, 3-year disease-free survival (DFS) would be recorded in the follow-up period.

Sample size estimation: In a previous study, the 3-year DFS was 96.6% for patients who were diagnosed as cT1 GGO dominated invasive lung adenocarcinoma and received lobectomy and SLND. We hypothesized that if the 3-year DFS was over 91.6% for patients who were diagnosed as cT1 GGO dominated invasive lung adenocarcinoma and received lobectomy and without SLND, we regarded that non-SLND group is no inferior to SLND group. In this context, the estimated sample size was 636. Considering 10% enrolled patients would loss in follow-up or not meet the inclusion criteria, the final sample size was 700.

In order to render the patients recruited in accordance with distribution of tumor location, we designed the random number table with stratification. In a previous study, for tumor location for cT1 GGO dominated invasion lung adenocarcinoma, 24.7% was in left upper lobe, 13.2% was in left lower lobe, 37.6% was in right upper lobe, 6.6% was in right middle lobe and 17.9% was in right lower lobe. Thus, we designed random number tables for each lobe according to the above proportion. The random number table for left upper lobe included 87 patients for either group. The table for left lower lobe included 46 patients for either group. The table for right upper lobe included 132 patients for either group. The table for right middle lobe included 23 patients for either group. The table for right lower lobe included 63 patients for either group. The total number of patients designed to enroll was 702.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 702 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial
• Estimated Study Start Date: December 1, 2021
• Estimated Primary Completion Date: December 1, 2024
• Estimated Study Completion Date: December 1, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Systematically mediastinal lymph node dissection group; Patient would receive systematically mediastinal lymph node dissection in surgery.	Procedure: Systematically mediastinal lymph node dissection; Patient would receive systematically mediastinal lymph node dissection in surgery in the two arms, respectively.
Experimental: No systematically mediastinal lymph node dissection group; Patient would not receive systematically mediastinal lymph node dissection in surgery.	Procedure: No systematically mediastinal lymph node dissection; Patient wouldn't receive systematically mediastinal lymph node dissection in surgery in the two arms, respectively.

Outcome Measures

Primary Outcome Measures :

1. Disease-free survival [ Time Frame: 3 years after the surgery ]
   Disease-free survival means the period after surgery when no disease can be detected.

Secondary Outcome Measures :

1. Overall survival [ Time Frame: 3 years after the surgery ]
   Overall survival means the period after surgery when a patient doesn't die directly from that disease or from an unrelated cause.
2. Rate of patients with perioperative complication [ Time Frame: 1 month after the surgery ]
   The perioperative complication includes wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc within a month after surgery.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients who have signed the informed consent form.
• Patients who had no history of other malignant tumors or received thoracic surgery;
• A single lesion detected on computed tomography (CT) scan featured as ground glass nodule(GGO) and C/T ratio ≤0.5;
• Lesion staged as clinical T1N0M0 and resectable by surgery;
• Histologically confirmed primary invasive lung adenocarcinoma preoperatively or intraoperatively;
• Patients had no history of radiation for thoracic region.

Exclusion Criteria:

• Not staged as clinical T1N0M0;
• Lesion is not resectable by surgery;
• Pathological diagnosis is other than invasive lung adenocarcinoma;
• Patients who had history of other malignant tumors;
• Patients who had received radiation or other treatments.

Contacts and Locations

Contacts

Contact: Haoxuan Wu, Dr.; 86-13901770461; haoxuanwu@hotmail.com

Contact: Haiquan Chen, Ph.D

Sponsors and Collaborators

Fudan University

Investigators

• Principal Investigator: Haiquan Chen, Ph.D; Shanghai Cancer Center

More Information

• Responsible Party: Haiquan Chen, Director, Fudan University
• ClinicalTrials.gov Identifier: NCT04527419
• Other Study ID Numbers: SLNDILA
• First Posted: August 26, 2020
• Last Update Posted: October 11, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Study Protocol, Inform Consent Form, Clinical Study Report would not be shared after the study begin.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haiquan Chen, Fudan University:

invasive lung adenocarcinoma; systematically mediastinal lymph node dissection; ground-glass nodule

Additional relevant MeSH terms:

Adenocarcinoma; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases