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VATS Lobectomy for Clinical Stage IB or II Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00425022
First received: January 19, 2007
Last updated: January 29, 2007
Last verified: January 2007

January 19, 2007
January 29, 2007
January 2007
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00425022 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
VATS Lobectomy for Clinical Stage IB or II Lung Cancer
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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Non-Small-Cell Lung
  • Thoracic Surgery, Video-Assisted
Procedure: thoracoscopy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
Not Provided

Inclusion Criteria:

  1. Histologic or cytologic diagnosis of non-small cell lung cancer.
  2. Clinical stage IB or II, according to the American Joint Committee on Cancer (AJCC).
  3. Tumor ≤ 6 cm in size amenable to surgical resection.
  4. Including clinical IB or II NSCLC after neoadjuvant therapy
  5. Performance status of 0-1 on ECOG scale.
  6. At least 18 years old.
  7. Patient compliance that allows adequate follow-up.
  8. Medical fitness of patients adequate for radical NSCLC surgery.
  9. 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.
  10. Signed informed consent from patient or legal representative.
  11. 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:

  1. Metastatic disease in workup
  2. Any T3, T4 lesion or N2, N3 lesion
  3. Concurrent administration of other tumor therapy, including radiotherapy, immunotherapy except chemotherapy.
  4. Active uncontrolled infection.
  5. Serious concomitant disorders that would compromise the safety of patient or compromise the patient’s ability to tolerate therapy.
  6. Significant neurological or mental disorder.
  7. Previous history of malignancy in any organ
  8. Pregnant or nursing.
Both
18 Years to 80 Years
No
Contact: Hyun-Sung Lee, MD, PhD +82-31-920-1648 thoracic@ncc.re.kr
Korea, Republic of
 
NCT00425022
NCCCTS-06-223
Not Provided
Not Provided
National Cancer Center, Korea
Not Provided
Principal Investigator: Hyun-Sung Lee, MD, PhD National Cancer Center, Korea
National Cancer Center, Korea
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP