Stage IA Non-small Cell Lung CancerOREX-IANCT03066297
Optimal Extent of Pulmonary Resection in Clinical Stage IA Non-Small Cell Lung Cancer
An observational study of Stage IA Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigatros hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in participants with clinical stage IA non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IA Non-small Cell Lung Cancer
- What is being tested?
- Extent of pulmonary resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,018 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2017to 15 Feb 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Patients who are planned to undergo surgery for clinical stage IA non-small cell lung cancer
Who may be able to join
- The following features should be fulfilled at preoperative thin-section CT scans
- Solitary lung nodule
- Lesion size is 3cm or less in its maximal dimension of the entire tumor
- The center of the tumor is located in the outer third of the lung field in either the transverse, coronal, or sagittal plane
- Lung cancer is suspected (or NSCLC if tissue diagnosis already obtained)
- Clinical stage T1a-bN0M0 (according to 7th AJCC staging system)
Show all 14Show fewer
- Absence of proximal segmental or lobar bronchial involvement.
- NSCLC must be confirmed in intraoperative frozen section biopsies or postoperative pathologic examinations if the lesion was not histologically confirmed before operation.
- Age ≥ 18 years and < 75 years.
- ECOG performance status 0-1.
- The patient should have adequate cardiopulmonary reserve to tolerate lobectomy (ppo FEV1 > 40% and ppo DLCO > 40% or VO2 max > 15ml kg-1 min-1)
- No prior chemotherapy or thoracic radiotherapy for any malignancy.
- No prior malignancy within 5 years from study entry (except for non-melanoma skin cancer, superficial bladder cancer, thyroid cancer or carcinoma in situ of the uterine cervix).
- The patient agrees to participate in the study and signs the informed consent form.
Who cannot join
- Histologic diagnosis other than NSCLC (such as small cell lung cancer, carcinoid, pulmonary lymphoma, or other benign lung disease, etc).
- Hilar or mediastinal lymph node metastasis suspected on imaging studies (CT or PET/CT) or confirmed preoperatively by EBUS or mediastinoscopy.
- Parietal pleura, chest wall, or mediastinal invasion is confirmed intraoperatively or postoperatively.
- M1a disease is confirmed intraoperatively or postoperatively.
- Bilobectomy, sleeve resection, pneumonectomy, concomitant wedge resection, or concomitant thoracic procedure (including cardiac surgery) is performed.
- Synchronous or metachronous multiple cancers (within the past 5 years).
Show all 10Show fewer
- Interstitial lung disease or severe pulmonary emphysema which makes it impossible to tolerate either lobectomy or sublobar resection.
- Active bacterial or fungal infection.
- Uncontrolled systemic disease which makes the patient medically unfit for thoracic surgery such as unstable angina, recent myocardial infarction, congestive heart failure, or end-stage renal or liver disease.
- Serious mental illness or psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Optimize the Extent of Pulmonary Resection According to the Decision-Making Algorithm in Patients With Clinical Stage IA Non-Small Cell Lung Cancer
The investigatros hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in participants with clinical stage IA non-small cell lung cancer.
The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm
The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.
Read the detailed description
- Background
- The standard extent of pulmonary resection for non-small cell lung cancer (NSCLC) is still lobectomy. However, recent advances in imaging technology and staging modalities and the widespread use of computed tomography (CT) screening have greatly increased the probability of detecting small-sized tumors, especially with ground-glass opacity (GGO) feature. Adenocarcinoma with GGO feature generally has a good prognosis due to its minimally invasive nature. Many studies have shown that these pathologically less invasive subtypes are associated with better prognoses compared with other subtypes such as acinar, papillary, micropapillary, and solid predominant invasive adenocarcinoma.
- This recent change in the disease pattern of NSCLC from locally advanced and solid tumors to early and less invasive tumors with GGO features have led to a resurgence of interest in sublobar resection. Several retrospective studies have been conducted to compare the early and late outcomes including long-term survival between patients who underwent lobectomy and those who underwent sublobar resection.
- Multiple reports have suggested that small-sized peripheral lung adenocarcinoma can be treated by sublobar resection, yielding survival rates similar to those of lobectomy. Lobectomy is considered to be too much for these less invasive tumors and sublobar resection would be sufficient for these tumors. If sublobar resection is equivalent to lobectomy in terms of their oncologic efficacy for the surgical treatment of NSCLC, the potential benefits of sublobar resection include (1) the preservation of vital lung parenchyma and pulmonary function, which may lead to improved early morbidities and mortalities and then late quality of life and (2) a chance for a second resection with a subsequent primary NSCLC.
- However, when considering the published evidence for sublobar resection, its interpretation needs to be cautious. Since most studies were non-randomized, there may also have been selection bias in terms of preoperative patient risk factors (intentional vs. compromised sublobar resection), tumors of various histological subtypes or different tumor size in the study arms. Therefore, the results from two randomized trials of lobectomy versus sublobar resection for small-sized lung cancer currently ongoing in Japan (Japan Clinical Oncology Group [0802]) and in the United States (Cancer and Leukemia Group B [140503]) need to be awaited.
- Based on these clinical circumstances and the published evidence, the investigators developed the decision-making algorithm regarding the surgical treatment for clinical stage IA NSCLC.
- Hypothesis The investigators hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in patients with clinical stage IA non-small cell lung cancer.
- Purpose The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm
- Study plan The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.
- Conditions
- Stage IA Non-small Cell Lung Cancer
- Being tested
- Extent of pulmonary resection
- Keywords
- Clinical stage IA non-small cell lung cancer, Lobectomy, Segmentectomy, Wedge resection, Sublobar resection, Limited resection
- 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.
Extent of pulmonary resectionProcedure or surgery
Extent of pulmonary resection selected based on the institutional decision-making algorithm
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy | Lobectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm | |
| Segmentectomy | Segmentectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm Receives: Procedure: Extent of pulmonary resection | |
| Wide wedge resection | Wide wedge resection will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm Receives: Procedure: Extent of pulmonary resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
the time from the date of the operation until the first recurrence or the last follow-up.
Measured: 5 years
Secondary outcomes (8)
Overall survival (OS)
the interval between the date of the operation and the date of death from any cause or the last follow-up
Measured: 5 years
Rate of loco-regional recurrence
Loco-regional recurrence means tumor recurrence within the ipsilateral hemithorax and mediastinum
Measured: 5 years
Rate of systemic recurrence
Systemic recurrence means tumor recurrence outside the bilateral hemithorax or mediastinum except for lung-to-lung metastasis
Measured: 5 years
Postoperative FEV1 (Forced expiratory volume in 1 second; Liter)
the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. This value reflects the pulmonary function of participants
Measured: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date
Postoperative DLco (Diffusing capacity of the lung for carbon monoxide; mL/mmHg/min)
the extent to which oxygen passes from the air sacs of the lungs into the blood. This value is also related to the pulmonary function of participants
Measured: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date
C/T ratio at thin section CT scans
C/T ratio is the consolidation/tumor ratio, which can be measured by the maximum diameter of consolidation to the maximum tumor diameter. Pathologic invasiveness of tumors can be predicted by this value.
Measured: within 2 months prior to operation date
Postoperative pathologic subtypes
(according to the 2015 WHO classification of lung tumors)
Measured: 1 month after operation date
Incidence of lymph node metastasis
The investigators will check the incidence of lymph node metastasis from the permanent pathology report.
Measured: within 1 month after operation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start15 Feb 2017
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IA Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,018 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Kwan Kim, Samsung Medical Center
- Investigators
- Hong Kwan Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066297
- Sponsor's protocol ID
- 2016-12-116
- Acronym
- OREX-IA
- Status last verified
- Dec 2023
- First submitted
- 15 Feb 2017
- Last updated
- 6 Dec 2023
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Optimize the Extent of Pulmonary Resection According to the Decision-Making Algorithm in Patients With Clinical Stage IA Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03066297
- Acronym / sponsor ID
- OREX-IA / 2016-12-116
- Conditions
- Stage IA Non-small Cell Lung Cancer
- Keywords
- Clinical stage IA non-small cell lung cancer, Lobectomy, Segmentectomy, Wedge resection, Sublobar resection, Limited resection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 28 Feb 2017 (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 investigatros hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in participants with clinical stage IA non-small cell lung cancer.
The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm
The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.
Detailed description
- Background
- The standard extent of pulmonary resection for non-small cell lung cancer (NSCLC) is still lobectomy. However, recent advances in imaging technology and staging modalities and the widespread use of computed tomography (CT) screening have greatly increased the probability of detecting small-sized tumors, especially with ground-glass opacity (GGO) feature. Adenocarcinoma with GGO feature generally has a good prognosis due to its minimally invasive nature. Many studies have shown that these pathologically less invasive subtypes are associated with better prognoses compared with other subtypes such as acinar, papillary, micropapillary, and solid predominant invasive adenocarcinoma.
- This recent change in the disease pattern of NSCLC from locally advanced and solid tumors to early and less invasive tumors with GGO features have led to a resurgence of interest in sublobar resection. Several retrospective studies have been conducted to compare the early and late outcomes including long-term survival between patients who underwent lobectomy and those who underwent sublobar resection.
- Multiple reports have suggested that small-sized peripheral lung adenocarcinoma can be treated by sublobar resection, yielding survival rates similar to those of lobectomy. Lobectomy is considered to be too much for these less invasive tumors and sublobar resection would be sufficient for these tumors. If sublobar resection is equivalent to lobectomy in terms of their oncologic efficacy for the surgical treatment of NSCLC, the potential benefits of sublobar resection include (1) the preservation of vital lung parenchyma and pulmonary function, which may lead to improved early morbidities and mortalities and then late quality of life and (2) a chance for a second resection with a subsequent primary NSCLC.
- However, when considering the published evidence for sublobar resection, its interpretation needs to be cautious. Since most studies were non-randomized, there may also have been selection bias in terms of preoperative patient risk factors (intentional vs. compromised sublobar resection), tumors of various histological subtypes or different tumor size in the study arms. Therefore, the results from two randomized trials of lobectomy versus sublobar resection for small-sized lung cancer currently ongoing in Japan (Japan Clinical Oncology Group [0802]) and in the United States (Cancer and Leukemia Group B [140503]) need to be awaited.
- Based on these clinical circumstances and the published evidence, the investigators developed the decision-making algorithm regarding the surgical treatment for clinical stage IA NSCLC.
- Hypothesis The investigators hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in patients with clinical stage IA non-small cell lung cancer.
- Purpose The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm
- Study plan The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lobectomy | – | –Lobectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm |
| Segmentectomy | – | Procedure: Extent of pulmonary resectionSegmentectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm |
| Wide wedge resection | – | Procedure: Extent of pulmonary resectionWide wedge resection will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are planned to undergo surgery for clinical stage IA non-small cell lung cancer
Key inclusion criteria (14 listed)
- The following features should be fulfilled at preoperative thin-section CT scans
- Clinical stage T1a-bN0M0 (according to 7th AJCC staging system)
- Absence of proximal segmental or lobar bronchial involvement.
- NSCLC must be confirmed in intraoperative frozen section biopsies or postoperative pathologic examinations if the lesion was not histologically confirmed before operation.
- Age ≥ 18 years and < 75 years.
Key exclusion criteria (10 listed)
- Histologic diagnosis other than NSCLC (such as small cell lung cancer, carcinoid, pulmonary lymphoma, or other benign lung disease, etc).
- Hilar or mediastinal lymph node metastasis suspected on imaging studies (CT or PET/CT) or confirmed preoperatively by EBUS or mediastinoscopy.
- Parietal pleura, chest wall, or mediastinal invasion is confirmed intraoperatively or postoperatively.
- M1a disease is confirmed intraoperatively or postoperatively.
- Bilobectomy, sleeve resection, pneumonectomy, concomitant wedge resection, or concomitant thoracic procedure (including cardiac surgery) is performed.
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 |
|---|---|---|
| Extent of pulmonary resectionExtent of pulmonary resection selected based on the institutional decision-making algorithm | Procedure or surgery | Segmentectomy, Wide wedge resection |
Primary outcome
Disease-free survival (DFS)
Time frame: 5 years
the time from the date of the operation until the first recurrence or the last follow-up.
8 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Rate of loco-regional recurrence
Time frame: 5 years
Rate of systemic recurrence
Time frame: 5 years
Postoperative FEV1 (Forced expiratory volume in 1 second; Liter)
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date
Postoperative DLco (Diffusing capacity of the lung for carbon monoxide; mL/mmHg/min)
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date
C/T ratio at thin section CT scans
Time frame: within 2 months prior to operation date
Postoperative pathologic subtypes
Time frame: 1 month after operation date
Incidence of lymph node metastasis
Time frame: within 1 month after operation date
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 6 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Stage IA Non-small Cell Lung Cancer
Not yet recruitingPhase 2
Study of Robotic Assisted/Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC
Stage IA NSCLC
Active, not recruitingObservational study
Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
RecruitingPhase 2
An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1/2
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
Non Small Cell Lung Cancer, Advanced Solid Tumor
Not yet recruitingPhase 1
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients
Squamous Non-Small Cell Lung Cancer sqNSCLC
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.
Hong Kwan Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IA Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 14 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2023. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 5 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 6 Dec 2023.