Clinical trial NCT00425022: VATS Lobectomy for Clinical Stage IB or II Lung Cancer
Official title: Feasibility of VATS(Video-Assisted Thoracoscopic Surgery) Lobectomy for Clinical Stage IB or II Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Thoracic Surgery, Video-Assisted
Keywords: lung cancer
video-assisted thoracic surgery
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2007-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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 criteria: 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.

Primary outcomes:
measure: To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung cancer.
measure: Success is defined as VATS lobectomy without conversion.
measure: If success rate over 90%, VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small cell lung cancer
Secondary outcomes:
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
measure: To estimate the reccurrence rate (locoregional and distant metastasis)
measure: To estimate the overall survival
measure: To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)
measure: To evaluate inflammatory mediators after VATS
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
affiliation: National Cancer Center, Korea
name: Hyun-Sung Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: