Non-small Cell Lung CancerNCT01707888
VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Peking University People's Hospital at 6 sites in China.
Trial summary
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Thoracoscopy/VATS
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 6 sitesChina
- Study dates
- Sep 2014to Jun 2017
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinical early stage(I/II) lung cancer
Who may be able to join
- Preoperative criteria:
- non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.
- No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
- No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or 1. (8) Sufficient organ functions. (9) Written informed consent.
Who cannot join
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- Psychosis.
- Systemic steroids medication.
Show all 9Show fewer
- Uncontrollable diabetes mellitus.
- Uncontrollable hypertension.
- History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100044
Songlei Ou
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100044
Keneng Chen
- Not yet recruiting
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100044
Hui Li
- Recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100044
Yuqing Huang
- Not yet recruiting
Beijing Friendship Hospital
Beijing
Zhi Gao
- Recruiting
Peking university people's hospital
Beijing
Jun Wang, MD
About this study
Official title: VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.
Read the detailed description
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Thoracoscopy/VATS
- 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.
Thoracoscopy/VATSProcedure or surgery
Also called Minimal invasive surgery
Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| major lung resection | Patients undergo major lung resection by thoracoscopy/VATS. Receives: Procedure: Thoracoscopy/VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity and mortility rate
perioperative complications and death rates of the group
Measured: 3 moths
Secondary outcomes (7)
Disease-free survival
To evaluate Disease Free Survival (DFS) of the group.
Measured: 3y
Rate of loco-regional and systemic recurrence
To evaluate the rate of loco-regional and systemic recurrence of the group.
Measured: 3y
Pulmonary function
to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.
Measured: 6 months after surgery
Postoperative hospital stay.
to evaluate the postoperative hospital stay of the group.
Measured: 3 months postoperatively
Postoperative drainage duration
to evaluate the postoperative drainage duration of the group.
Measured: 3 months postoperatively
overall survival
to evaluate the overall survival rate of the group.
Measured: 3 months postoperatively
converted rate
the rate of converted thoracotomy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (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 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
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, MD, Study chair, Peking University People's HospitalFan Yang, MD, Study director, Peking University People's HospitalZhao Xi Sui, MD, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707888
- Sponsor's protocol ID
- PEKUPH1201
- Status last verified
- Jan 2015
- First submitted
- 13 Oct 2012
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study
- ClinicalTrials.gov ID
- NCT01707888
- Acronym / sponsor ID
- PEKUPH1201
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 Oct 2012 (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.
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.
Detailed description
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| major lung resection | – | Procedure: Thoracoscopy/VATSPatients undergo major lung resection by thoracoscopy/VATS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinical early stage(I/II) lung cancer
Key inclusion criteria (4 listed)
- non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.
- No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
- No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or 1. (8) Sufficient organ functions. (9) Written informed consent.
Key exclusion criteria (9 listed)
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- Psychosis.
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 |
|---|---|---|
| Thoracoscopy/VATSAlso: Minimal invasive surgeryPatients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery. | Procedure or surgery | major lung resection |
Primary outcome
morbidity and mortility rate
Time frame: 3 moths
perioperative complications and death rates of the group
7 secondary outcomes
Disease-free survival
Time frame: 3y
Rate of loco-regional and systemic recurrence
Time frame: 3y
Pulmonary function
Time frame: 6 months after surgery
Postoperative hospital stay.
Time frame: 3 months postoperatively
Postoperative drainage duration
Time frame: 3 months postoperatively
overall survival
Time frame: 3 months postoperatively
converted rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Jun Wang, MD study chair
Peking University People's Hospital
Fan Yang, MD study director
Peking University People's Hospital
Zhao Xi Sui, MD study director
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?
An observational study of 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 4 inclusion and 9 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 27 Jan 2015. 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.
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, MD (88324078, Jwangmd@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity and mortility rate (time frame: 3 moths). 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 27 Jan 2015.