Carcinoma, Non-Small-Cell LungNCT03108560
Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
A study testing sublobar resection and lobectomy in people with Carcinoma, Non-Small-Cell Lung, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- sublobar resection and lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2017to 31 Dec 2023
- 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
- cT1N0M0 non-small-cell lung cancer
- ground-glass opacity, ≤2cm, GGO≥25%
- eligible for both lobectomy and sublobar resection
- intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma
- intraoperative pathology of biopsied station 10 lymph node is negative
Who cannot join
- intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ
- intraoperative pathology of biopsied station 10 lymph node is positive
- multiple GGOs, lesions other than dominant lesion are malignant or >5mm
- history of thoracic surgery
- history of malignancy in recent 5 years
- unstable systemic disease
- patients with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Di Ge, MD, 13681975917, ge.di@zs-hospital.sh.cn
About this study
Official title: A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- sublobar resection, lobectomy
- Keywords
- 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.
sublobar resectionProcedure or surgery
Patients receive sublobar resection, which includes wedge resection and segmentectomy.
lobectomyProcedure or surgery
patients receive lobectomy
| Study group | Role | What they receive |
|---|---|---|
| Sublobar group | Experimental | Patients receive sublobar resection, including wedge resection and segmentectomy. Receives: Procedure: sublobar resection |
| Lobectomy group | 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.
Overall Survival
survival status of patients after surgery
Measured: five years after surgery
Secondary outcomes (7)
Disease Free Survival
recurrence status of patients after surgery
Measured: five years after surgery
Local and distant recurrence rates
recurrence rate of local and distant locations respectively
Measured: five years after surgery
Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter
FEV1 of patients after surgery
Measured: 3rd, 6th, 12th, and 24th month after surgery
Pulmonary Function: forced vital capacity (FVC) in liter
FVC of patients after surgery
Measured: 3rd, 6th, 12th, and 24th month after surgery
Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg
DLCO of patients after surgery
Measured: 3rd, 6th, 12th, and 24th month after surgery
Morbidity rate
the rates of complications related to treatment during perioperative period
Measured: up to 30 days after surgery
Mortality rate
the rates of death related to treatment during perioperative period
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start18 Apr 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Fujian Medical University Union Hospital, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital
- Responsible party
- Sponsor
- Investigators
- Di Ge, MD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108560
- Sponsor's protocol ID
- ZSTS201701
- Status last verified
- Sep 2018
- First submitted
- 28 Mar 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of all case report forms are to be collected and shared with other researchers at the end of followup.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03108560
- Acronym / sponsor ID
- ZSTS201701
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- sublobar resection, lobectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Fujian Medical University Union Hospital, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Apr 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 incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublobar group | Experimental | Procedure: sublobar resectionPatients receive sublobar resection, including wedge resection and segmentectomy. |
| Lobectomy group | 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 (5 listed)
- cT1N0M0 non-small-cell lung cancer
- ground-glass opacity, ≤2cm, GGO≥25%
- eligible for both lobectomy and sublobar resection
- intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma
- intraoperative pathology of biopsied station 10 lymph node is negative
Key exclusion criteria (7 listed)
- intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ
- intraoperative pathology of biopsied station 10 lymph node is positive
- multiple GGOs, lesions other than dominant lesion are malignant or >5mm
- history of thoracic surgery
- history of malignancy in recent 5 years
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 |
|---|---|---|
| sublobar resectionPatients receive sublobar resection, which includes wedge resection and segmentectomy. | Procedure or surgery | Sublobar group |
| lobectomypatients receive lobectomy | Procedure or surgery | Lobectomy group |
Primary outcome
Overall Survival
Time frame: five years after surgery
survival status of patients after surgery
7 secondary outcomes
Disease Free Survival
Time frame: five years after surgery
Local and distant recurrence rates
Time frame: five years after surgery
Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter
Time frame: 3rd, 6th, 12th, and 24th month after surgery
Pulmonary Function: forced vital capacity (FVC) in liter
Time frame: 3rd, 6th, 12th, and 24th month after surgery
Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg
Time frame: 3rd, 6th, 12th, and 24th month after surgery
Morbidity rate
Time frame: up to 30 days after surgery
Mortality rate
Time frame: up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: Yes. The data of all case report forms are to be collected and shared with other researchers at the end of followup.
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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.
Di Ge, MD study chair
Fudan 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 sublobar resection and lobectomy in people with Carcinoma, Non-Small-Cell Lung, run by Shanghai Zhongshan 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 5 inclusion and 7 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 7 Sep 2018. 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 Junjie Xi, MD (8602164041990 ext. 2017, xi.junjie@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: five years after surgery). 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 7 Sep 2018.