Non-small Cell Lung CancerPhase 3NCT02481661
Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC
A Phase 3 study testing segmentectomy in people with Non-small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70y
- Preoperative criteria:
- ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.
- ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.
- Intraoperative criteria:
- ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.
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- ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible.
- ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.
- ECOG performance status 0-2.
- No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix).
- No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
- No prior chemotherapy or radiation therapy.
- Lobectomy is tolerated.
- Sufficient organ functions.
- Written informed consent.
Who cannot join
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) multiple cancers.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
- Psychosis.
- Uncontrollable diabetes mellitus.
- History of severe heart disease.
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- The maximal diameter of GGO≤5mm.
- N1, N2, or M1a is confirmed postoperatively.
- Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).
- Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.
- Confirmation of benign disease by postoperative pathologic examination.
- Lesion located in the middle lobe.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Changchun Wang, MM, +86-571-88128062, ccw7878@163.com
About this study
Official title: A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)
Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).
Read the detailed description
Objective: To compare the outcomes(including 5 year relapse free survival rate, 5 year overall survival rate, retaining pulmonary function and the rates of loco-regional and systemic recurrence ) of patients with peripheral stage IA (≤ 2 cm) non-small cell lung cancer undergoing anatomic segmentectomy vs lobectomy. And to evaluate whether the anatomic segmentectomy is an optimal type of surgery for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC).
Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
- Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- segmentectomy
- 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.
segmentectomyProcedure or surgery
segmentectomy in Arm I and lobectomy in Arm II
| Study group | Role | What they receive |
|---|---|---|
| segmentectomy | Experimental | Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS. Receives: Procedure: segmentectomy |
| lobectomy | Active comparator | Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS. Receives: Procedure: segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
To evaluate the 5 year relapse-free survival (RFS) rate of two groups.
Measured: 5 years
Secondary outcomes (4)
overall survival
To evaluate the 5 year overall survival (OS) rate of two groups.
Measured: 5 years
Pulmonary function
to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months and 12 months postoperatively.
Measured: 6 months and 12 months
the duration of postoperative hospital stay
to evaluate the postoperative inpatient days of the two groups.
Measured: an expected average of 5 days
performance status
to evaluate the postoperative performance status of the two groups by ECOG score standard.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481661
- Sponsor's protocol ID
- ZhejiangCH
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)
- ClinicalTrials.gov ID
- NCT02481661
- Acronym / sponsor ID
- ZhejiangCH
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 25 Jun 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.
Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).
Detailed description
Objective: To compare the outcomes(including 5 year relapse free survival rate, 5 year overall survival rate, retaining pulmonary function and the rates of loco-regional and systemic recurrence ) of patients with peripheral stage IA (≤ 2 cm) non-small cell lung cancer undergoing anatomic segmentectomy vs lobectomy. And to evaluate whether the anatomic segmentectomy is an optimal type of surgery for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC).
Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
- Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| segmentectomy | Experimental | Procedure: segmentectomyPatients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS. |
| lobectomy | Active comparator | Procedure: segmentectomyPatients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-70y
- Preoperative criteria:
- ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.
- ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.
- Intraoperative criteria:
Key exclusion criteria (12 listed)
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) multiple cancers.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
- Psychosis.
- Uncontrollable diabetes mellitus.
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 |
|---|---|---|
| segmentectomysegmentectomy in Arm I and lobectomy in Arm II | Procedure or surgery | lobectomy, segmentectomy |
Primary outcome
Relapse-free survival
Time frame: 5 years
To evaluate the 5 year relapse-free survival (RFS) rate of two groups.
4 secondary outcomes
overall survival
Time frame: 5 years
Pulmonary function
Time frame: 6 months and 12 months
the duration of postoperative hospital stay
Time frame: an expected average of 5 days
performance status
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing segmentectomy in people with Non-small Cell Lung Cancer, run by Zhejiang Cancer 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 12 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 25 Jun 2015. 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.
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 Weimin Mao, MD (+86-571-88122032, maowm1218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (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 25 Jun 2015.