Lung NeoplasmsNCT04944563
Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field
A study testing Segmentectomy and Lobectomy in people with Lung Neoplasms and Surgery, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms, Surgery
- 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
- 1,120 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 1 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18-75 years old;
- 6 mm ≤ tumor size ≤ 20 mm;
- 0.25 < CTR < 1;
- Center of tumor located in the middle third of the lung field;
- ECOG score of 0,1 or 2;
- Lung function (FEV1 ≥ 1 L and ≥ 70%);
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- Both lung segmentectomy and lobectomy could achieve R0 resection;
- No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
- No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
- Single tumor nodule or the concomitant nodule < microinvasive tumor;
- Written informed consent.
Who cannot join
- The tumor nodule is located in right middle lobe;
- A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
- Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
- A serious mental illness;
- Pregnant and lactating women;
- Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
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- With the history of cerebral infarction or cerebral hemorrhage within 6 months;
- With the history of sustained systemic corticosteroid therapy within 1 month;
- The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
- Other unsuitable situations;
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
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Zhihua Li, M.D., +86-02568303743, lizhihua_njmu@126.com
Liang Chen, M.D.
About this study
Official title: Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study
This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.
Read the detailed description
Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.
- Conditions
- Lung Neoplasms, Surgery
- Being tested
- Segmentectomy, Lobectomy
- Keywords
- Non-small cell lung cancer, Segmentectomy, Lobectomy, the middle third of the lung field
- 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.
SegmentectomyProcedure or surgery
Patients receive segmentectomy
LobectomyProcedure or surgery
Patients receive lobectomy
| Study group | Role | What they receive |
|---|---|---|
| Segmentectomy | Experimental | Patients receive segmentectomy Receives: Procedure: Segmentectomy |
| Lobectomy | Active comparator | Patients receive lobectomy Receives: Procedure: Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Disease-Free Survival
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Measured: From date of the recruitment, assessed up to 60 months
Secondary outcomes (4)
30-day Morbidity and mortality rates
The rates of complications and death related to treatment during perioperative period
Measured: From date of the recruitment, assessed up to 30 days
Pulmonary function in the first year after surgery
The Forced expiratory volume in one second (FEV1) in liter
Measured: From date of the 3rd, 6th, and 12th month after surgery
3-year Disease-Free-Survival
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Measured: From date of the recruitment, assessed up to 36 months
5-year overall Survival
The time interval from randomization to death caused by any reason
Measured: From date of the recruitment, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start20 Jul 2021
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang Chen, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944563
- Sponsor's protocol ID
- 2021-SR-164
- Status last verified
- Apr 2022
- First submitted
- 17 Jun 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12.
PubMed 30442588Nakamura K, Saji H, Nakajima R, Okada M, Asamura H, Shibata T, Nakamura S, Tada H, Tsuboi M. A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L). Jpn J Clin Oncol. 2010 Mar;40(3):271-4. doi: 10.1093/jjco/hyp156. Epub 2009 Nov 22.
PubMed 19933688Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9.
PubMed 31078312Wu WB, Xia Y, Pan XL, Wang J, He ZC, Xu J, Wen W, Xu XF, Zhu Q, Chen L. Three-dimensional navigation-guided thoracoscopic combined subsegmentectomy for intersegmental pulmonary nodules. Thorac Cancer. 2019 Jan;10(1):41-46. doi: 10.1111/1759-7714.12897. Epub 2018 Nov 3.
PubMed 30390378Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094.
PubMed 24551879Wu W, He Z, Xu J, Wen W, Wang J, Zhu Q, Chen L. Anatomical Pulmonary Sublobar Resection Based on Subsegment. Ann Thorac Surg. 2021 Jun;111(6):e447-e450. doi: 10.1016/j.athoracsur.2020.10.083. Epub 2021 Jan 30.
PubMed 33524360
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study
- ClinicalTrials.gov ID
- NCT04944563
- Acronym / sponsor ID
- 2021-SR-164
- Conditions
- Lung Neoplasms, Surgery
- Keywords
- Non-small cell lung cancer, Segmentectomy, Lobectomy, the middle third of the lung field
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 29 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 investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.
Detailed description
Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy | Experimental | Procedure: SegmentectomyPatients receive segmentectomy |
| Lobectomy | Active comparator | Procedure: LobectomyPatients receive lobectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient aged 18-75 years old;
- 6 mm ≤ tumor size ≤ 20 mm;
- 0.25 < CTR < 1;
- Center of tumor located in the middle third of the lung field;
- ECOG score of 0,1 or 2;
Key exclusion criteria (10 listed)
- The tumor nodule is located in right middle lobe;
- A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
- Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
- A serious mental illness;
- Pregnant and lactating women;
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 |
|---|---|---|
| SegmentectomyPatients receive segmentectomy | Procedure or surgery | Segmentectomy |
| LobectomyPatients receive lobectomy | Procedure or surgery | Lobectomy |
Primary outcome
5-year Disease-Free Survival
Time frame: From date of the recruitment, assessed up to 60 months
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
4 secondary outcomes
30-day Morbidity and mortality rates
Time frame: From date of the recruitment, assessed up to 30 days
Pulmonary function in the first year after surgery
Time frame: From date of the 3rd, 6th, and 12th month after surgery
3-year Disease-Free-Survival
Time frame: From date of the recruitment, assessed up to 36 months
5-year overall Survival
Time frame: From date of the recruitment, assessed up to 60 months
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 5 Apr 2022.
- Background: PubMed 30442588Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12.
- Background: PubMed 19933688Nakamura K, Saji H, Nakajima R, Okada M, Asamura H, Shibata T, Nakamura S, Tada H, Tsuboi M. A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L). Jpn J Clin Oncol. 2010 Mar;40(3):271-4. doi: 10.1093/jjco/hyp156. Epub 2009 Nov 22.
- Background: PubMed 31078312Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9.
- Background: PubMed 30390378Wu WB, Xia Y, Pan XL, Wang J, He ZC, Xu J, Wen W, Xu XF, Zhu Q, Chen L. Three-dimensional navigation-guided thoracoscopic combined subsegmentectomy for intersegmental pulmonary nodules. Thorac Cancer. 2019 Jan;10(1):41-46. doi: 10.1111/1759-7714.12897. Epub 2018 Nov 3.
- Background: PubMed 24551879Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094.
- Background: PubMed 33524360Wu W, He Z, Xu J, Wen W, Wang J, Zhu Q, Chen L. Anatomical Pulmonary Sublobar Resection Based on Subsegment. Ann Thorac Surg. 2021 Jun;111(6):e447-e450. doi: 10.1016/j.athoracsur.2020.10.083. Epub 2021 Jan 30.
- 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.
Liang Chen, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical 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 Segmentectomy and Lobectomy in people with Lung Neoplasms and Surgery, run by The First Affiliated Hospital with Nanjing Medical 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 11 inclusion and 10 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 5 Apr 2022. 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 Zhihua Li, M.D. (+86-025-68303743, lizhihua_njmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year Disease-Free Survival (time frame: From date of the recruitment, assessed up to 60 months). 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 NCT04944563, which also lists 6 linked publications.
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 5 Apr 2022.