Carcinoma, Non-Small-Cell LungNCT04527419
SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009)
A study testing No mediastinal lymph node dissection in people with Carcinoma, Non-Small-Cell Lung, run by Fudan University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- No mediastinal lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2022to 9 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haiquan Chen, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Haoxuan Wu, Doctor, (86)13901770461, haoxuanwu@hotmail.com
About this study
Official title: Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial
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
Read the detailed description
Following interim analysis of 302 patients revealed no lymph node metastasis in either study arm and 100% 2-year disease-free survival in both arms. The selective non-mediastinal lymph node dissection (non-SLND) arm had reduced complications (JCO 2025; doi:10.1200/JCO-25-00610). The study design has been amended to a single-arm prospective cohort. All enrolled patients meeting inclusion criteria will sign informed consent and receive non-SLND. The primary endpoint remains 3-year disease-free survival (DFS).
The sample size has been recalibrated to 545 patients based on historical control 3-year DFS of 96.6%, a stricter non-inferiority margin of 2.5%, 90% power, and the 1-sided alpha of 2.5%.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- No mediastinal lymph node dissection
- Keywords
- invasive lung adenocarcinoma; systematically mediastinal lymph node dissection; ground-glass nodule
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No mediastinal lymph node dissectionProcedure or surgery
No mediastinal lymph node dissection will be performed.
| Study group | Role | What they receive |
|---|---|---|
| No mediastinal lymph node dissection group | Experimental | Mediastinal lymph node dissection will not be performed. Receives: Procedure: No mediastinal lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival means the period after surgery when no disease can be detected.
Measured: 3 years after the surgery
Secondary outcomes (2)
Overall survival
Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.
Measured: 3 years after the surgery
Rate of patients with perioperative complications
The perioperative complication includes death, wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc.
Measured: 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start9 Feb 2022
- Primary completion21 Jul 2026 (estimated)
- Study completion9 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, Ph.D, Principal investigator, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527419
- Sponsor's protocol ID
- SLNDILA
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2020
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol, Inform Consent Form, Clinical Study Report would not be shared after the study begin.
Publications
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.
PubMed 40690727
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04527419
- Acronym / sponsor ID
- SLNDILA
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- invasive lung adenocarcinoma; systematically mediastinal lymph node dissection; ground-glass nodule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 9 Feb 2027 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Following interim analysis of 302 patients revealed no lymph node metastasis in either study arm and 100% 2-year disease-free survival in both arms. The selective non-mediastinal lymph node dissection (non-SLND) arm had reduced complications (JCO 2025; doi:10.1200/JCO-25-00610). The study design has been amended to a single-arm prospective cohort. All enrolled patients meeting inclusion criteria will sign informed consent and receive non-SLND. The primary endpoint remains 3-year disease-free survival (DFS).
The sample size has been recalibrated to 545 patients based on historical control 3-year DFS of 96.6%, a stricter non-inferiority margin of 2.5%, 90% power, and the 1-sided alpha of 2.5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No mediastinal lymph node dissection group | Experimental | Procedure: No mediastinal lymph node dissectionMediastinal lymph node dissection will not be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No mediastinal lymph node dissectionNo mediastinal lymph node dissection will be performed. | Procedure or surgery | No mediastinal lymph node dissection group |
Primary outcome
Disease-free survival
Time frame: 3 years after the surgery
Disease-free survival means the period after surgery when no disease can be detected.
2 secondary outcomes
Overall survival
Time frame: 3 years after the surgery
Rate of patients with perioperative complications
Time frame: 1 month after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 40690727Zhang 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.
- Individual participant dataSharing planned: No. Study Protocol, Inform Consent Form, Clinical Study Report would not be shared after the study begin.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haiquan Chen, Ph.D contact
Haiquan Chen, Ph.D principal investigator
Shanghai Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No mediastinal lymph node dissection in people with Carcinoma, Non-Small-Cell Lung, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haoxuan Wu, Dr. (86-13901770461, haoxuanwu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 3 years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.