VATS Lobectomy for Clinical Stage IB or II Lung Cancer - Full Text View

Sponsored by:	National Cancer Center, Korea
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00425022

Purpose

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

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Thoracic Surgery, Video-Assisted	Procedure: thoracoscopy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Feasibility of VATS(Video-Assisted Thoracoscopic Surgery) Lobectomy for Clinical Stage IB or II Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	40
Study Start Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425022

Contacts

Contact: Hyun-Sung Lee, MD, PhD

+82-31-920-1648

thoracic@ncc.re.kr

Locations

Korea, Republic of, Gyeonggi
National Cancer Center	Recruiting
Goyang, Gyeonggi, Korea, Republic of, 411-769
Contact: Hyun-Sung Lee, MD, PhD +82-31-920-1648 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

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

Principal Investigator:

Hyun-Sung Lee, MD, PhD

National Cancer Center, Korea

More Information

Video presentation about complete lymph node dissection under VATS This link exits the ClinicalTrials.gov site

Study ID Numbers:	NCCCTS-06-223
Study First Received:	January 19, 2007
Last Updated:	January 29, 2007
ClinicalTrials.gov Identifier:	NCT00425022
Health Authority:	Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:

lung cancer
video-assisted thoracic surgery

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009