Non-small Cell Lung CancerPhase 3STEPSNCT02360761
Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy
A Phase 3 study testing VATS and Thoracotomy in people with Non-small Cell Lung Cancer, run by Peking University People's Hospital at 6 sites in China.
Trial summary
The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- VATS and Thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 6 sitesChina
- Study dates
- Jan 2016to Jan 2022
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 70 years or older
- Preoperative criteria (contrast-enhanced Computed tomography scan)
- Suspected non-small cell lung cancer
- Clinical stage ⅠA, i.e. T1N0M0 (tumor diameter ≤3 cm, surrounded by visceral pleura, short-axis of lymph node <1 cm or cold lymph nodes on PET scan)
- The maximum diameter of consolidation of the maximum tumor diameter (consolidation/tumor ratio, C/T ratio) is no less than 0.5 in sub-solid lesions
- Eligible for sublobar resection with sufficient margin
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- Intraoperative criteria
- Histologically confirmed invasive NSCLC, i.e. NSCLC other than pre-invasive adenocarcinomas defined by The International Association for the Study of Lung Cancer (adenocarcinoma in situ, and minimally invasive adenocarcinoma)
- Pathological exclusion of suspected lymph nodes involvement
- Feasible to perform sublobar resection in terms of surgical margin requirement
- General criteria
- Must sign informed consent by the patient or his/her entrusted party
- Must complete 4-year mortality index and comprehensive geriatric assessment(CGA) if necessary
- The physiological reservation can tolerate lobectomy
Who cannot join
- Unable to comply with the study procedure
- Past thoracic surgery history, except for diagnostic thoracoscopy
- Malignant tumor history within the past 5 years, except for the following conditions: cured skin basal cell carcinoma, superficial bladder carcinoma, and uterine cervix cancer in situ
- Any active systemic diseases including uncontrolled hypertension, unstable angina pectoris, newly onset of angina pectoris within recent 3 months, congestive heart failure (class II or plus of New York Heart Association, NYHA), myocardial infarction within recent 6 months, severe disease in the need of medication such as arrhythmia, liver, renal or metabolic diseases
- Uncontrollable infections
- Coexisting small cell lung cancer
- Psychiatric diseases diagnosed
- Other circumstances which is deemed inappropriate for enrollment by the researchers
Trial locations and contacts
6 sites in 1 country.
Fan Yang, M.D. contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Haidian Hospital
Beijing
Yuqing Huang
- Recruiting
Peking university people's hospital
Beijing
Jun Wang, MD
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Fenglei Yu
- Recruiting
Sir Run Run Shaw Hospital
Hangzhao
Zhoumiao Chen
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Wenjie Jiao
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Song Zhao
About this study
Official title: Surgical Treatment of Elderly Patients With Early Stage Non-small Cell Lung Cancer (STEPS): Comparison Between Sublobar Resection and Lobectomy - an Open, Multicenter, Randomized Phase III Clinical Trial
The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these trials is under-represented, as in most of the ongoing clinical trials. This study focuses on the elderly population of early stage lung cancer, and aims to investigate the outcome of lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC) in elderly patients.
Read the detailed description
This randomized trial is to the best of our knowledge the first one designed to compare sublobar resection and lobectomy for elderly patients, in order to address these open questions:In patients aged 70 years or older and with clinical stage T1N0M0 NSCLC, (1) whether sublobar resection can achieve similar disease-free survival compared to lobectomy, (2) whether sublobar resection can reduce the postoperative mortality and morbidity,(3) whether sublobar resection can reserve better pulmonary function and quality of life for elderly patients of NSCLC?
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- VATS, Thoracotomy
- Keywords
- Lung cancer;Elderly;Sublobar resection;Lobectomy
- 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.
VATSProcedure or surgery
Also called Thoracoscopy
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
ThoracotomyProcedure or surgery
Also called Open surgery
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy | Active comparator | Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS). Receives: Procedure: VATS; Procedure: Thoracotomy |
| Sublobar resection | Experimental | Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS. Receives: Procedure: VATS; Procedure: Thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Disease free survival Event
The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason.
Measured: 3 years
Secondary outcomes (8)
Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.
Perioperative complication is defined as the complication occurred after surgery and before discharge, or within 30 days postoperatively. Death cases during this period should be recorded as perioperative death.
Measured: 1 months
Hospitalization time after surgery in Participants
Defined as the time interval from the day of operation to discharge.
Measured: 1 months
Intubation time after surgery in Participants
Defined as the time interval from the day of operation to extubation.
Measured: 1 months
Time To Overall survival Event
The time interval from randomization to death from any cause.
Measured: 3 years
Percentage of Participants With Local Recurrence and Metastasis Event
The ratio of local recurrence and metastasis in 3 years from the day of randomization
Measured: 3 years
Postoperative pulmonary function
The Forced expiratory volume in one second and the forced vital capacity at 6-, 12- and 36-month post of the day of randomization.
Measured: 3 years
Percentage of Participants With VATS procedure
The ratio of video assisted thoracoscopic surgery in each group.
Measured: 1 month
Scores on the quality of life questionaires
The scores of the 6-, 12- and 36-month questionaire on quality of life post of the day of randomization.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Jun Wang, M.M., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360761
- Sponsor's protocol ID
- CTONG1504
- Acronym
- STEPS
- Status last verified
- Sep 2016
- First submitted
- 24 Jan 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang F, Sui X, Chen X, Zhang L, Wang X, Wang S, Wang J. Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial. Trials. 2016 Apr 7;17:191. doi: 10.1186/s13063-016-1312-6.
PubMed 27053091
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Elderly Patients With Early Stage Non-small Cell Lung Cancer (STEPS): Comparison Between Sublobar Resection and Lobectomy - an Open, Multicenter, Randomized Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT02360761
- Acronym / sponsor ID
- STEPS / CTONG1504
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Lung cancer;Elderly;Sublobar resection;Lobectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 11 Feb 2015 (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 role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these trials is under-represented, as in most of the ongoing clinical trials. This study focuses on the elderly population of early stage lung cancer, and aims to investigate the outcome of lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC) in elderly patients.
Detailed description
This randomized trial is to the best of our knowledge the first one designed to compare sublobar resection and lobectomy for elderly patients, in order to address these open questions:In patients aged 70 years or older and with clinical stage T1N0M0 NSCLC, (1) whether sublobar resection can achieve similar disease-free survival compared to lobectomy, (2) whether sublobar resection can reduce the postoperative mortality and morbidity,(3) whether sublobar resection can reserve better pulmonary function and quality of life for elderly patients of NSCLC?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lobectomy | Active comparator | Procedure: VATS, Procedure: ThoracotomyPatients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS). |
| Sublobar resection | Experimental | Procedure: VATS, Procedure: ThoracotomyPatients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Aged 70 years or older
- Preoperative criteria (contrast-enhanced Computed tomography scan)
- Intraoperative criteria
- General criteria
Key exclusion criteria (8 listed)
- Unable to comply with the study procedure
- Past thoracic surgery history, except for diagnostic thoracoscopy
- Malignant tumor history within the past 5 years, except for the following conditions: cured skin basal cell carcinoma, superficial bladder carcinoma, and uterine cervix cancer in situ
- Any active systemic diseases including uncontrolled hypertension, unstable angina pectoris, newly onset of angina pectoris within recent 3 months, congestive heart failure (class II or plus of New York Heart Association, NYHA), myocardial infarction within recent 6 months, severe disease in the need of medication such as arrhythmia, liver, renal or metabolic diseases
- Uncontrollable infections
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 |
|---|---|---|
| VATSAlso: ThoracoscopyPatients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery. | Procedure or surgery | Lobectomy, Sublobar resection |
| ThoracotomyAlso: Open surgeryPatients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy. | Procedure or surgery | Lobectomy, Sublobar resection |
Primary outcome
Time To Disease free survival Event
Time frame: 3 years
The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason.
8 secondary outcomes
Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.
Time frame: 1 months
Hospitalization time after surgery in Participants
Time frame: 1 months
Intubation time after surgery in Participants
Time frame: 1 months
Time To Overall survival Event
Time frame: 3 years
Percentage of Participants With Local Recurrence and Metastasis Event
Time frame: 3 years
Postoperative pulmonary function
Time frame: 3 years
Percentage of Participants With VATS procedure
Time frame: 1 month
Scores on the quality of life questionaires
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Derived from this study: PubMed 27053091Yang F, Sui X, Chen X, Zhang L, Wang X, Wang S, Wang J. Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial. Trials. 2016 Apr 7;17:191. doi: 10.1186/s13063-016-1312-6.
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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.
Fan Yang, M.D. contact
Jun Wang, M.M. principal investigator
Peking University People's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VATS and Thoracotomy in people with Non-small Cell Lung Cancer, run by Peking University People's Hospital at 6 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 14 inclusion and 8 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jun Wang, M.M. (+8601088326650, Jwangmd@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To Disease free survival Event (time frame: 3 years). 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 NCT02360761, which also lists 1 linked publication.
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 20 Sep 2016.