Stage IA Non-small Cell Lung CancerNCT02288026
Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer
An observational study of Stage IA Non-small Cell Lung Cancer and Adenocarcinoma of the Lung, run by Capital Medical University at 1 site in China.
Trial summary
The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Stage IA Non-small Cell Lung Cancer, Adenocarcinoma of the Lung, Squamous Cell Lung Cancer
- How many people
- 630 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Dec 2017
- Phase
- Observational
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are stratified according to age and lesion type (GGO component ratio) two matching factor of 1: 2 to the lobectomy and sub-lobectomy surgery groups.
Who may be able to join
- clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
- T≤2cm，N0，M0.
- aged 60 to 80 years old.
- ECOG≤2.
- according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
- voluntary participation, signed informed consent.
Who cannot join
- pathologic stage is N1, N2, or M1a.
- received postoperative adjuvant therapy (chemotherapy or targeted therapy).
- radiotherapy or chemotherapy before surgery.
- small cell lung cancer
- benign lesions
- patient unwilling to cooperate with surgery or observation.
Trial locations and contacts
1 site in 1 country.
Xiuyi Zhi contact
Mu Hu contact
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital capital medical university
Beijing
Xiuyi Zhi, +86 10 83198287
About this study
The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.
Read the detailed description
Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients.
Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.
- Conditions
- Stage IA Non-small Cell Lung Cancer, Adenocarcinoma of the Lung, Squamous Cell Lung Cancer
- Keywords
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Bronchial Neoplasms
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Bronchial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Patients undergo lobectomy | |
| Arm II | Patients undergo a wedge resection or anatomical segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death
Secondary outcomes (2)
Overall survival
Measured: at least 5 years
Pulmonary function
Measured: Forced expiratory volume in one second, FEV1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2017 (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 Capital 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Chest Hospital, Beijing Tongren Hospital, Peking University First Hospital, China-Japan Friendship Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital, Beijing Anzhen Hospital, Peking University Cancer Hospital & Institute
- Responsible party
- Principal investigator, Xiuyi zhi, Xuanwu Hospital, Beijing
- Investigators
- Xiuyi Zhi, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288026
- Sponsor's protocol ID
- D14110700020000
- Status last verified
- Nov 2014
- First submitted
- 11 Oct 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02288026
- Acronym / sponsor ID
- D14110700020000
- Conditions
- Stage IA Non-small Cell Lung Cancer, Adenocarcinoma of the Lung, Squamous Cell Lung Cancer
- Keywords
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Bronchial Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Chest Hospital, Beijing Tongren Hospital, Peking University First Hospital, China-Japan Friendship Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital, Beijing Anzhen Hospital, Peking University Cancer Hospital & Institute
- Study start
- Sep 2014
- Primary completion
- Dec 2017 (estimated)
- First posted
- 11 Nov 2014 (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 compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.
Detailed description
Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients.
Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | – | –Patients undergo lobectomy |
| Arm II | – | –Patients undergo a wedge resection or anatomical segmentectomy |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are stratified according to age and lesion type (GGO component ratio) two matching factor of 1: 2 to the lobectomy and sub-lobectomy surgery groups.
Key inclusion criteria (6 listed)
- clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
- T≤2cm，N0，M0.
- aged 60 to 80 years old.
- ECOG≤2.
- according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
Key exclusion criteria (6 listed)
- pathologic stage is N1, N2, or M1a.
- received postoperative adjuvant therapy (chemotherapy or targeted therapy).
- radiotherapy or chemotherapy before surgery.
- small cell lung cancer
- benign lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival
Time frame: participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death
2 secondary outcomes
Overall survival
Time frame: at least 5 years
Pulmonary function
Time frame: Forced expiratory volume in one second, FEV1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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.
Xiuyi Zhi contact
Mu Hu contact
Xiuyi Zhi principal investigator
Xuanwu Hospital, Beijing
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 and Adenocarcinoma of the Lung, run by Capital 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 6 inclusion and 6 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 11 Nov 2014. 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 Xiuyi Zhi (+86 10 83198287), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death). 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 11 Nov 2014.