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

NCT04527419 | Recruiting DMC

• 1 other identifier: SLNDILA
• Study Type: interventional
• Target: 545
• Locations: 1 country
• Sites: 1

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Disease-free survival means the period after surgery when no disease can be detected.

  3 years after the surgery

Secondary Outcomes (2)

• Overall survival

  3 years after the surgery

• Rate of patients with perioperative complications

  1 month after the surgery

Study Arms (1)

No mediastinal lymph node dissection group

EXPERIMENTAL

Mediastinal lymph node dissection will not be performed.

Procedure: No mediastinal lymph node dissection

Interventions

No mediastinal lymph node dissection PROCEDURE

No mediastinal lymph node dissection will be performed.

No mediastinal lymph node dissection group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Related Publications (1)

• Zhang Y, Qian B, Song Q, Ma J, Cao H, Deng C, Wang S, Ye T, Xiang J, Zhang Y, Sun Y, Yan Y, Zheng S, Wu H, Huang Q, Hu H, Li Y, Fu F, Chen H. Phase III Study of Mediastinal Lymph Node Dissection for Ground Glass Opacity-Dominant Lung Adenocarcinoma. J Clin Oncol. 2025 Oct;43(28):3081-3089. doi: 10.1200/JCO-25-00610. Epub 2025 Jul 21.

  PMID: 40690727 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Haiquan Chen, Ph.D

  Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haoxuan Wu, Dr.

CONTACT

86-13901770461; haoxuanwu@hotmail.com

Haiquan Chen, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Treatment groups will be open to both patients and surgeons.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 26, 2020
• Study Start: February 9, 2022
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): February 9, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)