Lung AdenocarcinomaNCT04937283
Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
A study testing Segmentectomy and Lobectomy in people with Lung Adenocarcinoma, run by Shanghai Pulmonary Hospital, Shanghai, China at 14 sites in China.
Trial summary
This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Segmentectomy and Lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 14 sitesChina
- Study dates
- 1 Oct 2019to 30 Dec 2028
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 20-79 years old, both male or female;
- Tumor size <= 2cm on preoperative CT scan;
- Peripheral solitary nodule or the associated lesion is MIA or less invasive lesion;
- Preoperative CT indicated that the nodules were non-pure glass nodules (consolidation to tumor ratio >= 0.25);
- Intraoperative frozen section confirmed invasive lung adenocarcinoma with micropapillary and solid subtype negative (<= 5%);
- Intraoperative frozen section indicated the resection margins was free of tumor cells;
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- Lung function could withstand both lung segmentectomy and lobectomy (FEV1 > 1.5L or FEV1% >= 60%);
- Eastern Cooperative Oncology Group, 0 to 2;
- Volunteer to participate the trial and sign the informed consent, able to comply with the follow-up plan and other program requirements.
Who cannot join
- Radiological pure ground glass nodules (consolidation to tumor ratio < 0.25);
- The nodule is close to the lung hilus and is unable to perform segmentectomy;
- Intraoperative frozen section confirmed with micropapillary and solid subtype positive (> 5%);
- Intraoperative frozen section confirmed adenocarcinoma in situ and minimally invasive adenocarcinoma;
- Preoperative imaging examination or EBUS indicated lymph node positive metastasis;
- Preoperative imaging examination revealed distant metastasis;
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- Patients with severe damage to heart, liver and kidney function (grade 3 ~ 4, ALT and/or AST over 3 times the normal upper limit, Cr over the normal upper limit);
- Patients with other malignant tumors;
- Pregnant, planned pregnancy and lactating female patients (urine HCG>2500IU/L is diagnosed as early pregnancy);
- Prior chemotherapy, radiation therapy or any other therapies were performed; 12 participated in other tumors within three months of relevant clinical subjects;
- Those who have participated in other tumor-related clinical trials within three months;
- Those are not suitable for participating in trials according to investigator's assessment.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Junqiang Fan
- Recruiting
Anhui Chest Hospital
Hefei, Anhui
Ning Xu
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Mingran Xie
- Recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
Qibin Shen
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong
Feng Jin
Yunzeng Zhang
- Recruiting
The Sixth People's Hospital of Nantong
Nantong, Jiangsu, 216002
Xuedong Zhang
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Honggang Ke
- Recruiting
Nanyang Central Hospital
Nanyang, Henan
Xinwei Dong
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang
Xinjian Li
- Recruiting
Ningbo No.2 Hospital
Ningbo, Zhejiang
Guofang Zhao
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Chang Chen, MD, PhD, +86-021-65115006 ext. 2074, chenthoracic@163.com
- Recruiting
Huadong Hospital
Shanghai, Shanghai Municipality
Xiaoyong Shen
- Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Hao Xu
- Recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu
Jian Sun
About this study
Official title: Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Negative by Intraoperative Frozen Sections: A Prospective and Multi-center Randomized Controlled Trial Study
This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.
Read the detailed description
At present, the technology of intraoperative frozen section has gradually matured, which can diagnose the benign and malignant tumors and guide the resection strategy for peripheral small-sized lung adenocarcinoma. Travis et al. reported high specificity of intraoperative frozen section in the identification of micropapillary components, confirming that intraoperative frozen section may guide the selection of surgical procedures. However, there is still little evidence weather segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the non-inferiority in recurrence free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma (≤ 2 cm) not including micropapillary components.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Segmentectomy, Lobectomy
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SegmentectomyProcedure or surgery
Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
LobectomyProcedure or surgery
Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
| Study group | Role | What they receive |
|---|---|---|
| Segmentectomy | Experimental | Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed after a comprehensive evaluation. As with lobectomy, systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated in the same manner as with lobectomy. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy. Receives: Procedure: Segmentectomy |
| Lobectomy | Active comparator | lobectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively.
The distance from the dissection margin to the tumor edge must be evaluated intraoperatively. If the distance is either less than the maximum tumor diameter or ,20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery. Receives: Procedure: Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival rate
Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause
Measured: 5 year
Secondary outcomes (5)
overall survival
Overall survival (OS) was defined as the time from surgery until death from any cause
Measured: 5 year
Post-operative respiratory function
The post-operative respiratory function will be evaluated by FEV1% and FVC.
Measured: 6 months
Operation time
The surgery time in both groups.
Measured: 24 hours
Blood loss
Intraoperative blood loss in total.
Measured: 24 hours
Perioperative morbidity or mortality
Any intraoperative and postoperative complications related to the surgery.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Oct 2019
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- segmentectomy group versus lobectomy group
- Masking
- None (open label)
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deping Zhao, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Chang Chen, MD, PhD, Principal investigator, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937283
- Sponsor's protocol ID
- STAR001
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2021
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Negative by Intraoperative Frozen Sections: A Prospective and Multi-center Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT04937283
- Acronym / sponsor ID
- STAR001
- Conditions
- Lung Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Jun 2021 (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 study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.
Detailed description
At present, the technology of intraoperative frozen section has gradually matured, which can diagnose the benign and malignant tumors and guide the resection strategy for peripheral small-sized lung adenocarcinoma. Travis et al. reported high specificity of intraoperative frozen section in the identification of micropapillary components, confirming that intraoperative frozen section may guide the selection of surgical procedures. However, there is still little evidence weather segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the non-inferiority in recurrence free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma (≤ 2 cm) not including micropapillary components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- segmentectomy group versus lobectomy group
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy | Experimental | Procedure: SegmentectomySegmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed after a comprehensive evaluation. As with lobectomy, systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated in the same manner as with lobectomy. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy. |
| Lobectomy | Active comparator | Procedure: Lobectomylobectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intraoperatively. If the distance is either less than the maximum tumor diameter or ,20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient aged 20-79 years old, both male or female;
- Tumor size <= 2cm on preoperative CT scan;
- Peripheral solitary nodule or the associated lesion is MIA or less invasive lesion;
- Preoperative CT indicated that the nodules were non-pure glass nodules (consolidation to tumor ratio >= 0.25);
- Intraoperative frozen section confirmed invasive lung adenocarcinoma with micropapillary and solid subtype negative (<= 5%);
Key exclusion criteria (12 listed)
- Radiological pure ground glass nodules (consolidation to tumor ratio < 0.25);
- The nodule is close to the lung hilus and is unable to perform segmentectomy;
- Intraoperative frozen section confirmed with micropapillary and solid subtype positive (> 5%);
- Intraoperative frozen section confirmed adenocarcinoma in situ and minimally invasive adenocarcinoma;
- Preoperative imaging examination or EBUS indicated lymph node positive metastasis;
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 |
|---|---|---|
| SegmentectomySegmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery. | Procedure or surgery | Segmentectomy |
| LobectomyLobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery. | Procedure or surgery | Lobectomy |
Primary outcome
recurrence-free survival rate
Time frame: 5 year
Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause
5 secondary outcomes
overall survival
Time frame: 5 year
Post-operative respiratory function
Time frame: 6 months
Operation time
Time frame: 24 hours
Blood loss
Time frame: 24 hours
Perioperative morbidity or mortality
Time frame: 1 month
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 13 Apr 2026.
- 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.
Chang Chen, MD, PhD principal investigator
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmentectomy and Lobectomy in people with Lung Adenocarcinoma, run by Shanghai Pulmonary Hospital, Shanghai, China at 14 sites 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 12 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 Hang Su (+86 13917810850, dreamsuhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free survival rate (time frame: 5 year). 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 13 Apr 2026.