NCT00862004

Brief Summary

The purpose of this study is to examine the feasibility of video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer. Success is defined as VATS major pulmonary resection with SND without conversion. If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 2, 2010

Status Verified

March 1, 2009

Enrollment Period

8 months

First QC Date

March 13, 2009

Last Update Submit

February 1, 2010

Conditions

Non-small Cell Lung Cancer

Keywords

video-assisted thoracoscopic surgery (VATS)systematic node dissection (SND)stage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer (Success is defined as VATS major pulmonary resection with SND without conversion).

    2 month

Secondary Outcomes (1)

  • To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)

    6 months

Interventions

VATSPROCEDURE

video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
  • Stage IIIA (T1-3, N2, M0): N2 disease confirmed by any of the following: Mediastinoscopy; Bronchoscopy with fine-needle aspiration or esophagoscopy; or PET scan
  • ECOG performance status 0-1
  • Hematopoietic: WBC at least 4,000/mm\^3; Platelet count at least 100,000/mm\^3
  • Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
  • Renal: Creatinine clearance greater than 60 ml/min
  • Cardiovascular: Cardiac function normal

You may not qualify if:

  • Severe complications or infections
  • Pregnant or breast-feeding women
  • Clinically significant heart disease
  • Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
  • Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (3)

  • Watanabe A, Mishina T, Ohori S, Koyanagi T, Nakashima S, Mawatari T, Kurimoto Y, Higami T. Is video-assisted thoracoscopic surgery a feasible approach for clinical N0 and postoperatively pathological N2 non-small cell lung cancer? Eur J Cardiothorac Surg. 2008 May;33(5):812-8. doi: 10.1016/j.ejcts.2008.01.064. Epub 2008 Mar 14.

    PMID: 18342533RESULT

  • He J, Yang Y, Chen M. [Lobectomy by video-assisted thoracoscopic surgery]. Zhonghua Wai Ke Za Zhi. 1996 Feb;34(2):76-8. Chinese.

    PMID: 9388326RESULT

  • Shao WL, Liu LX, He JX, Yang YY, Chen HZ, Wu ZF, Wei B, Yin WQ, Yang DK. [Bronchial sleeve resection and reconstruction of pulmonary artery by video-assisted thoracic small incision surgery for central lung cancer: a report of 139 cases]. Zhonghua Wai Ke Za Zhi. 2007 Nov 15;45(22):1530-2. Chinese.

    PMID: 18282386RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Jianxing He, MD, FACS

    Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

    STUDY CHAIR

Central Study Contacts

Jianxing He, MD, FACS

CONTACT

+86-20-83337792drjianxing.he@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

February 2, 2010

Record last verified: 2009-03

Locations

CN(1)