VATS Lobectomy for Clinical Stage IB or II Lung Cancer

January 29, 2007 updated by: National Cancer Center, Korea

Feasibility of VATS(Video-Assisted Thoracoscopic Surgery) Lobectomy for Clinical Stage IB or II Non-Small Cell Lung Cancer

To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung cancer. Success is defined as VATS lobectomy without conversion. If success rate over 90%, VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small cell lung cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Procedure: thoracoscopy

Detailed Description

Video-assisted or minimally invasive surgery has become the standard approach for many abdominal surgical operations such as cholecystectomy and fundoplication. With respect to the thorax, video-assisted thoracoscopic surgery(VATS) is the accepted technique for biopsy of the lung and pleura and surgical treatment of pneumothorax.Thoracoscopic, also termed video-assisted thoracoscopic lobectomy has become accepted as a safe and effective procedure to treat early-stage non-small cell lung cancer (NSCLC). Several pilot series of thoracoscopic lobectomy in stage I lung cancer patients have been reported, demonstrating low complication rates and effective short-term and long-term oncologic results. With increasing experience, the indications for thoracoscopic lobectomy have been expanded. Single and Multi-institutional studies have demonstrated that thoracoscopic lobectomy is not only a safe and feasible technique, but is also associated with decreased morbidity, including shorter length of hospitalization and chest tube duration, decreased postoperative pain, improved preservation of pulmonary function, reduced inflammatory response as measured by lower postoperative cytokine levels, and shorter recovery time, as compared with conventional thoracotomy. The advantages of thoracoscopic lobectomy have been demonstrated in patients with clinical stage I NSCLC, and this strategy has been found to be particularly useful for specific subsets of patients such as the elderly and those patients with poor performance status.

The purpose of this study is to know whether VATS lobectomy for clinical stage IB or II non-small cell lung cancer is possible.

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- Gyeonggi
  - Goyang, Gyeonggi, Korea, Republic of, 411-769
    - Recruiting
    - National Cancer Center
    - Contact:
      
      Hyun-Sung Lee, MD, PhD
      
      Phone Number: +82-31-920-1648
      
      Email: thoracic@ncc.re.kr
    - Sub-Investigator:
      
      Jae Ill Zo, MD,PhD
    - Sub-Investigator:
      
      Jong Mog Lee, MD
    - Sub-Investigator:
      
      Moon Soo Kim, MD
    - Sub-Investigator:
      
      Bin Hwangbo, MD
    - Sub-Investigator:
      
      Hee Seok Lee, MD
    - Sub-Investigator:
      
      Hyae Young Kim, MD, PhD
    - Sub-Investigator:
      
      Kun Young Lim, MD
    - Sub-Investigator:
      
      Soo-Hyun Lee, MD
    - Sub-Investigator:
      
      Geon Kook Lee, MD, PhD
    - Sub-Investigator:
      
      Moon Woo Seong, MD
    - Sub-Investigator:
      
      Byoung-ho Nam, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologic or cytologic diagnosis of non-small cell lung cancer.
Clinical stage IB or II, according to the American Joint Committee on Cancer (AJCC).
Tumor ≤ 6 cm in size amenable to surgical resection.
Including clinical IB or II NSCLC after neoadjuvant therapy
Performance status of 0-1 on ECOG scale.
At least 18 years old.
Patient compliance that allows adequate follow-up.
Medical fitness of patients adequate for radical NSCLC surgery.
Adequate organ function including the following:Adequate hematologic function: WBC count ³ 4,000/uL, absolute neutrophil count (ANC) ³ 1,500/uL, platelet count ³ 100,000/uL, and hemoglobin ³ 10 gm/dL.Adequate hepatic function: bilirubin £ 1.5 x UNL, ALT or AST £ 2.5 x UNL.Adequate renal function: creatinine £ 1.5mg/dL.
Signed informed consent from patient or legal representative.
Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.

Exclusion Criteria:

Metastatic disease in workup
Any T3, T4 lesion or N2, N3 lesion
Concurrent administration of other tumor therapy, including radiotherapy, immunotherapy except chemotherapy.
Active uncontrolled infection.
Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
Significant neurological or mental disorder.
Previous history of malignancy in any organ
Pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung cancer.
Success is defined as VATS lobectomy without conversion.
If success rate over 90%, VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small cell lung cancer

Secondary Outcome Measures

Outcome Measure
To evaluate the number of dissected lymph nodes and the rate of contamination during lymph node dissection according to the lymph node stations under VATS
To estimate the reccurrence rate (locoregional and distant metastasis)
To estimate the overall survival
To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)
To evaluate inflammatory mediators after VATS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

Principal Investigator: Hyun-Sung Lee, MD, PhD, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Video presentation about complete lymph node dissection under VATS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 22, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2007

Last Update Submitted That Met QC Criteria

January 29, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NCCCTS-06-223

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