Status:
UNKNOWN
VATS Lobectomy for Clinical Stage IB or II Lung Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Carcinoma, Non-Small-Cell Lung
Thoracic Surgery, Video-Assisted
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 i...
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-assis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00425022
Start Date
January 1 2007
Last Update
January 30 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 411-769