VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer

NCT ID: NCT01707888

Last Updated: 2015-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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major lung resection

Patients undergo major lung resection by thoracoscopy/VATS.

Thoracoscopy/VATS

Intervention Type PROCEDURE

Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.

Interventions

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Thoracoscopy/VATS

Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.

Intervention Type PROCEDURE

Other Intervention Names

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Minimal invasive surgery

Eligibility Criteria

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Inclusion Criteria

Preoperative criteria:

i) 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.

(4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).

(5) 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.

Exclusion Criteria

1. Active bacterial or fungous infection.
2. Simultaneous or metachronous (within the past 5 years) double cancers.
3. Women during pregnancy or breast-feeding.
4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
5. Psychosis.
6. Systemic steroids medication.
7. Uncontrollable diabetes mellitus.
8. Uncontrollable hypertension.
9. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Wang

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Wang, MD

Role: STUDY_CHAIR

Peking University People's Hospital

Fan Yang, MD

Role: STUDY_DIRECTOR

Peking University People's Hospital

Zhao Xi Sui, MD

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Beijing Haidian Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Friendship Hospital

Beijing, , China

Site Status NOT_YET_RECRUITING

Peking university people's hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Wang, MD

Role: CONTACT

Facility Contacts

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Songlei Ou

Role: primary

Keneng Chen

Role: primary

Hui Li

Role: primary

Yuqing Huang

Role: primary

Zhi Gao

Role: primary

Jun Wang, MD

Role: primary

Other Identifiers

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PEKUPH1201

Identifier Type: -

Identifier Source: org_study_id

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