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VATS Lobectomy for Clinical Stage IB or II Lung Cancer

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

thoracoscopy

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring lung cancer, video-assisted thoracic surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

National Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

NCT ID

NCT00425022

First Posted

January 19, 2007

Last Updated

January 29, 2007

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00425022

Brief Title

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

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

lung cancer, video-assisted thoracic surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

thoracoscopy

Primary Outcome Measure Information:

Title

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

Title

Success is defined as VATS lobectomy without conversion.

Title

If success rate over 90%, VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small cell lung cancer

Secondary Outcome Measure Information:

Title

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

Title

To estimate the reccurrence rate (locoregional and distant metastasis)

Title

To estimate the overall survival

Title

To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)

Title

To evaluate inflammatory mediators after VATS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun-Sung Lee, MD, PhD

Phone

+82-31-920-1648

thoracic@ncc.re.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun-Sung Lee, MD, PhD

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center

City

Goyang

State/Province

Gyeonggi

ZIP/Postal Code

411-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyun-Sung Lee, MD, PhD

Phone

+82-31-920-1648

thoracic@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Jae Ill Zo, MD,PhD

First Name & Middle Initial & Last Name & Degree

Jong Mog Lee, MD

First Name & Middle Initial & Last Name & Degree

Moon Soo Kim, MD

First Name & Middle Initial & Last Name & Degree

Bin Hwangbo, MD

First Name & Middle Initial & Last Name & Degree

Hee Seok Lee, MD

First Name & Middle Initial & Last Name & Degree

Hyae Young Kim, MD, PhD

First Name & Middle Initial & Last Name & Degree

Kun Young Lim, MD

First Name & Middle Initial & Last Name & Degree

Soo-Hyun Lee, MD

First Name & Middle Initial & Last Name & Degree

Geon Kook Lee, MD, PhD

First Name & Middle Initial & Last Name & Degree

Moon Woo Seong, MD

First Name & Middle Initial & Last Name & Degree

Byoung-ho Nam, PhD

12. IPD Sharing Statement

Links:

URL

http://www.ctsnet.org

Description

Video presentation about complete lymph node dissection under VATS

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VATS Lobectomy for Clinical Stage IB or II Lung Cancer

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