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

Phase 2
18 Years
80 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung, Thoracic Surgery, Video-Assisted

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Trial Information

Feasibility of VATS(Video-Assisted Thoracoscopic Surgery) Lobectomy 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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung cancer.

Principal Investigator

Hyun-Sung Lee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Thoracic Surgery, Video-Assisted
  • lung cancer
  • video-assisted thoracic surgery
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms