Lung Cancer (NSCLC)NCT06634979
Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm
A study testing Selective lymph node dissection in people with Lung Cancer (NSCLC) and Lymph Node Dissection, run by Fudan University at 1 site in China.
Trial summary
The study investigated the efficacy and safety of a selective lymph node strategy (no lower mediastinal lymph node dissection for upper lobe tumors and no upper mediastinal lymph node dissection for lower lobe tumors) in patients with 0.5 < CTR < 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer (NSCLC), Lymph Node Dissection
- What is being tested?
- Selective lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 May 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in a clinical study and be willing to follow and have the ability to complete all trial procedures;
- Age 18-80 years at time of signing informed consent (including threshold);
- ECOG score 0 or 1;
- No previous surgery for lung cancer;
- Intraoperative or postoperative pathologically confirmed non-small cell lung cancer;
- Single pulmonary nodule with mixed ground glass on CT, or multiple pulmonary nodules but the main lesion is the above nodules;
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- The proportion of solid components of the nodule is between 0.5 and 1, and the total size of the nodule is less than or equal to 2 cm;
- Patients with clinical stage T1N0M0 surgically resectable;
- Primary treatment without radiotherapy or chemotherapy.
Who cannot join
- T1N0M0 with a clinical stage other than 0.5 < CTR < 1 and a diameter of ≤ 2 cm;
- Inability to perform complete surgical resection;
- cytology or histopathology confirms that it is a lung malignant tumor other than non-small cell lung cancer;
- Previous surgery for lung cancer;
- Patients who have received radiotherapy or chemotherapy for non-primary treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Penghao Deng, +86 13278979834, 18301050196@fudan.edu.cn
About this study
Official title: Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial
The study investigated the efficacy and safety of a selective lymph node strategy (no lower mediastinal lymph node dissection for upper lobe tumors and no upper mediastinal lymph node dissection for lower lobe tumors) in patients with 0.5 < CTR < 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 0.5 < CTR < 1 and ≤ 2 cm in diameter.
Read the detailed description
Selective lymph node dissection is an important idea to reduce the trauma of mediastinal lymph node dissection in early clinical patients. In a previous study, our team proposed a predictive model for mediastinal lymph node metastasis in patients with clinical T1N0 non-small cell lung cancer, and found that age, tumor size, central type, and pathologic subtype were closely related to mediastinal lymph node metastasis. In addition, our team found that adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), and invasive adenocarcinoma with predominantly adherent subtype (LPA) did not have mediastinal lymph node metastasis, and lymph node dissection was not necessary for such patients. In addition, by retrospectively studying nearly 3,000 cases of stage I-III NSCLC, we found that NSCLCs in the apical segments do not metastasize to the lower mediastinum, whereas in N1 lymph node-negative patients with negative pleural invasion, tumors in segments of the upper lobes do not metastasize to the lower mediastinal lymph nodes. On this basis, we conducted the first international prospective phase II clinical trial of a selective lymph node dissection strategy to validate the clinical feasibility of a selective lymph node dissection strategy. The main objective of this study was to develop a selective lymph node dissection strategy for cT1NOM0 invasive NSCLC with a diameter of ≤2 cm, i.e., no lower mediastinal lymph node dissection for tumors located in the upper lobe, and no upper mediastinal lymph node dissection for tumors located in the lower lobe. Further, we retrospectively analyzed 7067 NSCLC cases with systematic lymph node dissection from April 2008 to July 2022, in which the rate of mediastinal lymph node metastasis was 15.4% (1091/7067), and there was no lymph node metastasis in 209 cases of AIS/MIA/LPA, whereas in other subtypes of adenocarcinomas, the rate of mediastinal lymph node metastasis was 15.3% (106 /695). Among them, we retrospectively analyzed 360 cases of cT1N0M0 non-small cell lung cancer with 0.5 < CTR < 1.0 and found that among them, tumors located in the upper lobe had no lower mediastinal lymph node metastasis, and tumors located in the lower lobe had no metastasis in the upper mediastinal lymph nodes. For other non-small cell lung cancers with 0.5 < CTR < 1.0, if the VPI was negative, no lower mediastinal metastasis was also observed in tumors in the upper lobe and no upper mediastinal metastasis was observed in tumors in the lower lobe. In 212 cases of lung cancer not exceeding 1 cm in size, there were no lower mediastinal metastases in tumors in the upper lobe and no upper mediastinal metastases in tumors in the lower lobe.
The study investigated the efficacy and safety of a sex-selective lymph node strategy (no lower mediastinal lymph node clearance for upper lobe tumors and no upper mediastinal lymph node clearance for lower lobe tumors) in patients with 0.5 < CTR < 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 0.5 < CTR < 1 and ≤ 2 cm in diameter.
- Conditions
- Lung Cancer (NSCLC), Lymph Node Dissection
- Being tested
- Selective lymph node dissection
- Keywords
- Selective lymph node dissection
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective lymph node dissectionProcedure or surgery
For 0.5 < CTR < 1 and ≤ 2 cm diameter cT1N0M0 invasive non-small cell lung cancer patient sex for selective lymph node (lower mediastinal lymph nodes are not required to be cleared for upper lobe tumors and upper mediastinal lymph nodes are not required to be cleared for lower lobe tumors)
| Study group | Role | What they receive |
|---|---|---|
| Arm Selective lymph node dissection | Experimental | Lower mediastinal lymph node clearance is not required for upper lobe tumors and upper mediastinal lymph node clearance is not required for lower lobe tumors in the group Receives: Procedure: Selective lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year disease-free survival
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (1)
2-year overall survival
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies 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
- 684 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, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634979
- Sponsor's protocol ID
- ECTOP-1027
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial
- ClinicalTrials.gov ID
- NCT06634979
- Acronym / sponsor ID
- ECTOP-1027
- Conditions
- Lung Cancer (NSCLC), Lymph Node Dissection
- Keywords
- Selective lymph node dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 10 Oct 2024 (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.
The study investigated the efficacy and safety of a selective lymph node strategy (no lower mediastinal lymph node dissection for upper lobe tumors and no upper mediastinal lymph node dissection for lower lobe tumors) in patients with 0.5 < CTR < 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 0.5 < CTR < 1 and ≤ 2 cm in diameter.
Detailed description
Selective lymph node dissection is an important idea to reduce the trauma of mediastinal lymph node dissection in early clinical patients. In a previous study, our team proposed a predictive model for mediastinal lymph node metastasis in patients with clinical T1N0 non-small cell lung cancer, and found that age, tumor size, central type, and pathologic subtype were closely related to mediastinal lymph node metastasis. In addition, our team found that adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), and invasive adenocarcinoma with predominantly adherent subtype (LPA) did not have mediastinal lymph node metastasis, and lymph node dissection was not necessary for such patients. In addition, by retrospectively studying nearly 3,000 cases of stage I-III NSCLC, we found that NSCLCs in the apical segments do not metastasize to the lower mediastinum, whereas in N1 lymph node-negative patients with negative pleural invasion, tumors in segments of the upper lobes do not metastasize to the lower mediastinal lymph nodes. On this basis, we conducted the first international prospective phase II clinical trial of a selective lymph node dissection strategy to validate the clinical feasibility of a selective lymph node dissection strategy. The main objective of this study was to develop a selective lymph node dissection strategy for cT1NOM0 invasive NSCLC with a diameter of ≤2 cm, i.e., no lower mediastinal lymph node dissection for tumors located in the upper lobe, and no upper mediastinal lymph node dissection for tumors located in the lower lobe. Further, we retrospectively analyzed 7067 NSCLC cases with systematic lymph node dissection from April 2008 to July 2022, in which the rate of mediastinal lymph node metastasis was 15.4% (1091/7067), and there was no lymph node metastasis in 209 cases of AIS/MIA/LPA, whereas in other subtypes of adenocarcinomas, the rate of mediastinal lymph node metastasis was 15.3% (106 /695). Among them, we retrospectively analyzed 360 cases of cT1N0M0 non-small cell lung cancer with 0.5 < CTR < 1.0 and found that among them, tumors located in the upper lobe had no lower mediastinal lymph node metastasis, and tumors located in the lower lobe had no metastasis in the upper mediastinal lymph nodes. For other non-small cell lung cancers with 0.5 < CTR < 1.0, if the VPI was negative, no lower mediastinal metastasis was also observed in tumors in the upper lobe and no upper mediastinal metastasis was observed in tumors in the lower lobe. In 212 cases of lung cancer not exceeding 1 cm in size, there were no lower mediastinal metastases in tumors in the upper lobe and no upper mediastinal metastases in tumors in the lower lobe.
The study investigated the efficacy and safety of a sex-selective lymph node strategy (no lower mediastinal lymph node clearance for upper lobe tumors and no upper mediastinal lymph node clearance for lower lobe tumors) in patients with 0.5 < CTR < 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 0.5 < CTR < 1 and ≤ 2 cm in diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Selective lymph node dissection | Experimental | Procedure: Selective lymph node dissectionLower mediastinal lymph node clearance is not required for upper lobe tumors and upper mediastinal lymph node clearance is not required for lower lobe tumors in the group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Volunteer to participate in a clinical study and be willing to follow and have the ability to complete all trial procedures;
- Age 18-80 years at time of signing informed consent (including threshold);
- ECOG score 0 or 1;
- No previous surgery for lung cancer;
- Intraoperative or postoperative pathologically confirmed non-small cell lung cancer;
Key exclusion criteria (5 listed)
- T1N0M0 with a clinical stage other than 0.5 < CTR < 1 and a diameter of ≤ 2 cm;
- Inability to perform complete surgical resection;
- cytology or histopathology confirms that it is a lung malignant tumor other than non-small cell lung cancer;
- Previous surgery for lung cancer;
- Patients who have received radiotherapy or chemotherapy for non-primary treatment.
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 |
|---|---|---|
| Selective lymph node dissectionFor 0.5 < CTR < 1 and ≤ 2 cm diameter cT1N0M0 invasive non-small cell lung cancer patient sex for selective lymph node (lower mediastinal lymph nodes are not required to be cleared for upper lobe tumors and upper mediastinal lymph nodes are not required to be cleared for lower lobe tumors) | Procedure or surgery | Arm Selective lymph node dissection |
Primary outcome
2-year disease-free survival
Time frame: From enrollment to the end of treatment at 2 years
1 secondary outcome
2-year overall survival
Time frame: From enrollment to the end of treatment at 2 years
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 12 Aug 2025.
- Individual participant dataSharing planned: No
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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 principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective lymph node dissection in people with Lung Cancer (NSCLC) and Lymph Node Dissection, 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 9 inclusion and 5 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 12 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 Penghao Deng (+86-13278979834, 18301050196@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year disease-free survival (time frame: From enrollment to the end of treatment at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.