VATS Major Lung Resection for Chinese Early-stage Non-sma... | NCT01707888

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

NCT01707888

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Jan 27, 2015Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

Thoracoscopy/VATS

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Oct 13, 2012

First Submission Date that Met QC Criteria

Oct 15, 2012

First Posted Date

Oct 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2015

Last Update Posted Date

Jan 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
major lung resection		Patients undergo major lung resection by thoracoscopy/VATS.	Procedure: Thoracoscopy/VATS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracoscopy/VATS	Procedure	Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.	major lung resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
morbidity and mortility rate	perioperative complications and death rates of the group	3 moths

Secondary Outcomes

Measure	Description	Time Frame
Disease-free survival	To evaluate Disease Free Survival (DFS) of the group.	3y
Rate of loco-regional and systemic recurrence	To evaluate the rate of loco-regional and systemic recurrence of the group.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

clinical early stage(I/II) lung cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Wang, MD	Contact	88324078		Jwangmd@yahoo.com

Overall Officials

Name	Affiliation	Role
Jun Wang, MD	Peking University People's Hospital	Study Chair
Fan Yang, MD	Peking University People's Hospital	Study Director
Zhao Xi Sui, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital	Not yet recruiting	Beijing	Beijing Municipality	100044	China

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms