Carcinoma, Non-Small-Cell LungPhase 2NCT00425022
VATS Lobectomy for Clinical Stage IB or II Lung Cancer
A Phase 2 study testing thoracoscopy in people with Carcinoma, Non-Small-Cell Lung and Thoracic Surgery, Video-Assisted, run by National Cancer Center, Korea at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Thoracic Surgery, Video-Assisted
- What is being tested?
- thoracoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 411-769
Hyun-Sung Lee, MD, PhD, +82-31-920-1648, thoracic@ncc.re.kr
Jae Ill Zo, MD,PhD
About this study
Official title: Feasibility of VATS(Video-Assisted Thoracoscopic Surgery) Lobectomy for Clinical Stage IB or II Non-Small Cell Lung Cancer
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
Read the 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.
- Being tested
- thoracoscopy
- Keywords
- lung cancer, video-assisted thoracic surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Hyun-Sung Lee, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425022
- Sponsor's protocol ID
- NCCCTS-06-223
- Status last verified
- Jan 2007
- First submitted
- 19 Jan 2007
- Last updated
- 30 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of VATS(Video-Assisted Thoracoscopic Surgery) Lobectomy for Clinical Stage IB or II Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00425022
- Acronym / sponsor ID
- NCCCTS-06-223
- Keywords
- lung cancer, video-assisted thoracic surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jan 2007
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracoscopy | Procedure or surgery | – |
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2007.
- Video presentation about complete lymph node dissection under VATSLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun-Sung Lee, MD, PhD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thoracoscopy in people with Carcinoma, Non-Small-Cell Lung and Thoracic Surgery, Video-Assisted, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Sung Lee, MD, PhD (+82-31-920-1648, thoracic@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung cancer.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2007; AzTrials last refreshed its copy on 7 Nov 2026.