Lung NeoplasmsNCT02718365
Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA NSCLC
A study testing Wedge resection and Segmentectomy in people with Lung Neoplasms and Surgery, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. 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?
- Wedge resection and Segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,382 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2017to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions:
- Lung cancer is suspected.
- Lesion size is more than 5 mm but equal to or less than 20 mm.
- Consolidation/tumor (C/T) ratio is equal to or less than 0.25.
- The center of the tumor is located in the outer third of the lung field.
- Preoperative TSCT estimates a surgical margin of more than1.5 cm or the tumor's diameter.
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- Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging).
- R0 resectable in segmentectomy and wedge resections plus mediastinal lymph node resection.
- Aged 18 to 75 years old.
- No prior chemotherapy or thoracic radiation therapy for any malignant diseases.
- Preoperative FEV1.0>=1.0 L.
- Performance status of ECOG 0 or 1.
- Preoperative ASA scoring (American society of anesthesiology) class I -III.
- Sufficient organ functions.
- The patient agrees to participate in the trial and signs the informed consent form.
Who cannot join
- Quit smoking <2 weeks.
- Preoperative FEV1 < 50% of the expected value.
- Mediastinal lymph node metastasis confirmed by biopsy.
- Pregnant or lactating women.
- Serious mental illness.
- With other malignant disease history within 5 years.
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- With the history of unstable angina or myocardial infarction within 6 months.
- With the history of cerebral infarction or cerebral hemorrhage within 6 months.
- With the history of sustained systemic corticosteroid therapy within 1 month.
- The patient requires simultaneous surgical treatment of other diseases.
- TSCT shows that the lesion is located in the right middle lobe.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Hu Liao, MD
Lunxu Liu, MD, PhD
About this study
Official title: A Multi-center, Prospective, Randomized Controlled Clinical Trial: Comparison Between Wedge Resection and Segmentectomy in the Surgical Treatment of Ground Glass Opacity-dominant Stage IA Non-small Cell Lung Cancer
The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC. However, one critical question needs to be addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al. reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive. Therefore, these lesions are potential candidates for wedge resection. This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.
Read the detailed description
- Selection procedures: When a case meets the inclusion criteria and does not meet exclusion criteria, the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the trial. The following rules will be strictly applied:
- The application and confirmation of eligibility should be preoperatively completed and any postoperative application will not be accepted.
- If the Eligibility Application Form is incomplete, it must be returned to be completed; otherwise, it will not be accepted.
- After being approved by the Research Committee, the case will be assigned a number (Baseline Number, BN) and an Eligibility Confirmation Notice will be sent to the applicant.
- After each research participating center receives the Eligibility Confirmation Notice, the research assistant of each center is responsible for the custody and documentation.
- Once being selected for registration, the content of the Eligibility Application Form will be input into the database and the case's eligibility is not allowed to be cancelled, that is, the relevant information cannot be deleted from the database, unless the patient declines the information to be used in this study.
- The data center will not accept any duplicated applications for any single case. If this happens, the first registered data will be used (i.e., the first time BN).
- In cases of duplicated applications or registration errors, the research assistant of each research participating center shall contact the Research Committee as soon as possible for liaison and documentation.
- Qualification of the responsible surgeons who participate in this study: the responsible surgeons who participate in this study shall meet the following qualifications: 1) at least have completed 20 cases of VATS segmentectomy; and 2) have passed the blind review of his/her video records of the surgery.
- Criteria for confirming operation quality: for the case to be included in the analysis, the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures.
- Rules for handling the excluded patients identified intraoperatively: if the responsible surgeon finds that the patient in operation meets the exclusion criteria, the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol.
- Conditions
- Lung Neoplasms, Surgery
- Being tested
- Wedge resection, Segmentectomy
- Keywords
- Lung Neoplasms, Surgery, VATS, GGO, GGN, Segmentectomy, Wedge Resection, Prognosis
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wedge resectionProcedure or surgery
A wedge resection is the surgical removal of the lung tumor with a small portion of the lung that surrounds the tumor. Hilar and mediastinal lymph nodes should be resected or sampled.
SegmentectomyProcedure or surgery
A segmentectomy removes a segment of a lung lobe anatomically, or inclusion of a portion of adjacent segment, but does not remove the whole lung lobe. Hilar and mediastinal lymph nodes should be resected or sampled.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Wedge resection Receives: Procedure: Wedge resection |
| Group B | Active comparator | Segmentectomy Receives: Procedure: Segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Progression-Free-Survival
Measured: From date of the recruitment, assessed up to 60 months
Secondary outcomes (5)
3-year Progression-Free-Survival
Measured: From date of the recruitment, assessed up to 36 months
5-year overall survival
Measured: From date of the recruitment, assessed up to 60 months
Pulmonary function in the first year after surgery
Measured: From date of the 1 month\ 3 months\ 6 months\ 12 months after surgery in every recruited patient
30-day Morbidity and mortality rates
Measured: From date of the recruitment, assessed up to 30 days
10-year overall survival
Measured: From date of the recruitment, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start7 Dec 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 West China HospitalThe 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
- 1,382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lunxu Liu, West China Hospital
- Investigators
- Lunxu Liu, M.D., Ph.D., Principal investigator, Department of Thoracic Surgery, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718365
- Sponsor's protocol ID
- TSCI002
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2015
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641Zhang Y, Sun Y, Wang R, Ye T, Zhang Y, Chen H. Meta-analysis of lobectomy, segmentectomy, and wedge resection for stage I non-small cell lung cancer. J Surg Oncol. 2015 Mar;111(3):334-40. doi: 10.1002/jso.23800. Epub 2014 Oct 16.
PubMed 25322915Hida Y, Teramura K, Muto J, Ohtaka K, Hase R, Nakada R, Watanabe Y, Matsui Y, Kaga K. [Indication of limited pulmonary resection for small-sized lung cancer based on preoperative clinical data]. Kyobu Geka. 2012 Jan;65(1):52-7. Japanese.
PubMed 22314158Tsutani 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 24551879Cho JH, Choi YS, Kim J, Kim HK, Zo JI, Shim YM. Long-term outcomes of wedge resection for pulmonary ground-glass opacity nodules. Ann Thorac Surg. 2015 Jan;99(1):218-22. doi: 10.1016/j.athoracsur.2014.07.068. Epub 2014 Nov 15.
PubMed 25440277
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized Controlled Clinical Trial: Comparison Between Wedge Resection and Segmentectomy in the Surgical Treatment of Ground Glass Opacity-dominant Stage IA Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02718365
- Acronym / sponsor ID
- TSCI002
- Conditions
- Lung Neoplasms, Surgery
- Keywords
- Lung Neoplasms, Surgery, VATS, GGO, GGN, Segmentectomy, Wedge Resection, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,382 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Mar 2016 (estimated)
- 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 purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC. However, one critical question needs to be addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al. reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive. Therefore, these lesions are potential candidates for wedge resection. This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.
Detailed description
- Selection procedures: When a case meets the inclusion criteria and does not meet exclusion criteria, the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the trial. The following rules will be strictly applied:
- The application and confirmation of eligibility should be preoperatively completed and any postoperative application will not be accepted.
- If the Eligibility Application Form is incomplete, it must be returned to be completed; otherwise, it will not be accepted.
- After being approved by the Research Committee, the case will be assigned a number (Baseline Number, BN) and an Eligibility Confirmation Notice will be sent to the applicant.
- After each research participating center receives the Eligibility Confirmation Notice, the research assistant of each center is responsible for the custody and documentation.
- Once being selected for registration, the content of the Eligibility Application Form will be input into the database and the case's eligibility is not allowed to be cancelled, that is, the relevant information cannot be deleted from the database, unless the patient declines the information to be used in this study.
- The data center will not accept any duplicated applications for any single case. If this happens, the first registered data will be used (i.e., the first time BN).
- In cases of duplicated applications or registration errors, the research assistant of each research participating center shall contact the Research Committee as soon as possible for liaison and documentation.
- Qualification of the responsible surgeons who participate in this study: the responsible surgeons who participate in this study shall meet the following qualifications: 1) at least have completed 20 cases of VATS segmentectomy; and 2) have passed the blind review of his/her video records of the surgery.
- Criteria for confirming operation quality: for the case to be included in the analysis, the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures.
- Rules for handling the excluded patients identified intraoperatively: if the responsible surgeon finds that the patient in operation meets the exclusion criteria, the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Wedge resectionWedge resection |
| Group B | Active comparator | Procedure: SegmentectomySegmentectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions:
- Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging).
- R0 resectable in segmentectomy and wedge resections plus mediastinal lymph node resection.
- Aged 18 to 75 years old.
- No prior chemotherapy or thoracic radiation therapy for any malignant diseases.
Key exclusion criteria (11 listed)
- Quit smoking <2 weeks.
- Preoperative FEV1 < 50% of the expected value.
- Mediastinal lymph node metastasis confirmed by biopsy.
- Pregnant or lactating women.
- Serious mental illness.
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 |
|---|---|---|
| Wedge resectionA wedge resection is the surgical removal of the lung tumor with a small portion of the lung that surrounds the tumor. Hilar and mediastinal lymph nodes should be resected or sampled. | Procedure or surgery | Group A |
| SegmentectomyA segmentectomy removes a segment of a lung lobe anatomically, or inclusion of a portion of adjacent segment, but does not remove the whole lung lobe. Hilar and mediastinal lymph nodes should be resected or sampled. | Procedure or surgery | Group B |
Primary outcome
5-year Progression-Free-Survival
Time frame: From date of the recruitment, assessed up to 60 months
5 secondary outcomes
3-year Progression-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
Pulmonary function in the first year after surgery
Time frame: From date of the 1 month\ 3 months\ 6 months\ 12 months after surgery in every recruited patient
30-day Morbidity and mortality rates
Time frame: From date of the recruitment, assessed up to 30 days
10-year overall survival
Time frame: From date of the recruitment, assessed up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Background: PubMed 25322915Zhang Y, Sun Y, Wang R, Ye T, Zhang Y, Chen H. Meta-analysis of lobectomy, segmentectomy, and wedge resection for stage I non-small cell lung cancer. J Surg Oncol. 2015 Mar;111(3):334-40. doi: 10.1002/jso.23800. Epub 2014 Oct 16.
- Background: PubMed 22314158Hida Y, Teramura K, Muto J, Ohtaka K, Hase R, Nakada R, Watanabe Y, Matsui Y, Kaga K. [Indication of limited pulmonary resection for small-sized lung cancer based on preoperative clinical data]. Kyobu Geka. 2012 Jan;65(1):52-7. Japanese.
- 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 25440277Cho JH, Choi YS, Kim J, Kim HK, Zo JI, Shim YM. Long-term outcomes of wedge resection for pulmonary ground-glass opacity nodules. Ann Thorac Surg. 2015 Jan;99(1):218-22. doi: 10.1016/j.athoracsur.2014.07.068. Epub 2014 Nov 15.
- 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. This study is not recruiting at the moment.
Lunxu Liu, M.D., Ph.D. principal investigator
Department of Thoracic Surgery, West China Hospital, Sichuan 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 Wedge resection and Segmentectomy in people with Lung Neoplasms and Surgery, run by West China Hospital 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 15 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Liao, M.D. (+86 28 85422494, liaotiger_198653@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year Progression-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 NCT02718365, which also lists 5 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 12 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.