VATS Lobectomy for Clinical Stage IB or II Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00425022
• Other study ID #: NCCCTS-06-223
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2007
• Last updated: January 29, 2007
• Start date: January 2007

Study information

• Verified date: January 2007
• Source: National Cancer Center, Korea
• Contact: Hyun-Sung Lee, MD, PhD
• Phone: +82-31-920-1648
• Email: thoracic[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• thoracoscopy

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung cancer.
Primary	Success is defined as VATS lobectomy without conversion.
Primary	If success rate over 90%, VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small cell lung cancer
Secondary	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
Secondary	To estimate the reccurrence rate (locoregional and distant metastasis)
Secondary	To estimate the overall survival
Secondary	To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)
Secondary	To evaluate inflammatory mediators after VATS

External Links

•   Video presentation about complete lymph node dissection under VATS