VATS Lobectomy for Clinical Stage IB or II Lung Cancer

NCT00425022 | Unknown Phase 2

• 1 other identifier: NCCCTS-06-223
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

lung cancer; video-assisted thoracic surgery

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• 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

Interventions

thoracoscopy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 411-769, South Korea

RECRUITING

Related Links

• Video presentation about complete lymph node dissection under VATS

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Hyun-Sung Lee, MD, PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Sung Lee, MD, PhD

CONTACT

+82-31-920-1648; thoracic@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 22, 2007
• Study Start: January 1, 2007
• Last Updated: January 30, 2007

Record last verified: 2007-01

Locations

KR (1)