Lung CancerNCT03185754
Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer
A study testing Sublobar resection and lobectomy in people with Lung Cancer and Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
A multi-center prospective randomized trial in Taiwan to investigate whether sublobar resection, as compared to lobectomy, can offer equivalent clinical results to treat early non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Lung Cancer, Surgery
- What is being tested?
- Sublobar resection and lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jun 2013to 31 Dec 2023
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early non-small cell lung cancer (stage Ia) with diameter of two centimeters or less.
- Tumor locating at the peripheral lung parenchyma (outer one third in CT imaging).
- No suspected hilar or mediastinal lymph nodes metastasis in the CT or PET imaging study.
Who cannot join
- Tumor diameter more than 2 centimeter
- Hilar or mediastinal lymphnode metastasis by the cancer.
- Patients received previous surgery in the ipsi-lateral lung
- Lung tumor locating in the central lung parenchyma unable to obtain curative resection by sublobar resection.
- Patients with poor cardiopulmonary function unsuitable for receiving surgical resection.
- Patients who have multiple lung cancer or other suspicious lesion in the lung.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jang-Ming Lee, 02-23123456 ext. 65123, jangming@ntuh.gov.tw
Pei-Weng Yang, 02-23123456 ext. 65071, jmlee@ntu.edu.tw
About this study
A multi-center prospective randomized trial in Taiwan to investigate whether sublobar resection, as compared to lobectomy, can offer equivalent clinical results to treat early non-small cell lung cancer.
Read the detailed description
Background: Lung cancer has become an important disease threatening the public health world-wide. Surgical resection is the standard of care for treating non-small cell lung cancer in early stage. For decades, pulmonary lobectomy with lymph node dissection remains the gold standard of surgical approach. Pulmonary sublobar resection with pulmonary wedge resection or segmentectomy was reserved for the patients with high surgical risk, who were unsuitable for radical surgical resection. Pulmonary sublobar resection for tumor less than three centimeter was demonstrated to associated with higher risk of tumor recurrence or worsening survival outcome as compared to that done by lobectomy. 1 However, these data was which was not necessarily applicable to patients with early lung cancer with tumor of smaller size which was more frequently detected with the health screening test by CT scan in general population now. Although several retrospective studies has demonstrated that sublobar resection can offer a similar survival outcome after surgery as compared to that done by standard lobectomy once the tumor was smaller than two centimeter 2, there is still no consensus about the role of sublobar resection for these small early lung cancer. In general, there are several factors associating with higher risk of local recurrence which should be avoided for sublobar resection, including resection margin less than 2 cm or less than the diameter of the tumor itself 3, more obvious speculation in CT image or central location which makes it difficult to obtain adequate resection margin 4,5. Therefore, sublobar resection should be applied to the patients of early lung cancer when two cm of resection margin is achievable. The central location , obvious tumor infiltration in image study or presence of lymph node metastasis should be also avoided.
Patients and methods: The study will include surgical patients from six medical centers in Taiwan. All of the patients will receive complete study about the surgical risk and tumor staging before surgery. The patients will receive general anesthesia and pulmonary resection as the standard procedures including division of pulmonary vessels and bronchus. Either VATS (Video-assisted thoracoscopic surgery) or open surgery is acceptable for the surgical approaches. The patients will be randomly assigned to lobectomy and sublobar resection groups. Two cm of resection margin will be obtained in each patient in the sublobar resection group by wedge resection or segmentectomy. Standard lymph node dissection including the pulmonary hilum and mediastinum will be done in both groups of patients. For suspicious of pulmonary hilum or mediastinal lymph node metastasis, frozen pathological examination will be requested.
Post operative care and follow-up: The patients will be transferred to intensive care unit or surgical recovery room after surgery. Medication for pain control and postoperative rehabilitation education will be given to each patient after surgery. The chest tube will be removed after daily discharge less than 100 to 200 ml without air-leakage, adequate lung expansion noted in chest X ray imaging. The patient will be discharged from the hospital one or two days after removal of the chest tube. Whole body bone scan and CT scan will be given in every 6 months at least after surgery for postoperative follow-up.
- Conditions
- Lung Cancer, Surgery
- Being tested
- Sublobar resection, lobectomy
- Keywords
- lung cancer, surgery, lobectomy, sublobar resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublobar resectionProcedure or surgery
Sublobar resection
lobectomyProcedure or surgery
lobectomy
| Study group | Role | What they receive |
|---|---|---|
| early phase lung cancer | Experimental | sublobar resection and lobectomy Receives: Procedure: Sublobar resection; Procedure: lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Measured: 5 years
Secondary outcomes (4)
post-operative complication
defined as any deviation from the normal postoperative course
Measured: 3 months
Hospitalization time
the time interval from the day of surgery to discharge
Measured: 3 months
Chest tube duration
the time interval from the day of surgery to the day of chest tube removal
Measured: 3 months
post-operative pulmonary function
the pulmonary function at 6, 12, and 24 months post-operation
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start12 Jun 2013
- Primary completion15 Nov 2020 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Jang-Ming, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185754
- Sponsor's protocol ID
- 201212107RIND
- Status last verified
- Nov 2020
- First submitted
- 13 Jun 2013
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995 Sep;60(3):615-22; discussion 622-3. doi: 10.1016/0003-4975(95)00537-u.
PubMed 7677489Sienel W, Dango S, Kirschbaum A, Cucuruz B, Horth W, Stremmel C, Passlick B. Sublobar resections in stage IA non-small cell lung cancer: segmentectomies result in significantly better cancer-related survival than wedge resections. Eur J Cardiothorac Surg. 2008 Apr;33(4):728-34. doi: 10.1016/j.ejcts.2007.12.048. Epub 2008 Feb 7.
PubMed 18261918Kodama K, Doi O, Higashiyama M, Yokouchi H. Intentional limited resection for selected patients with T1 N0 M0 non-small-cell lung cancer: a single-institution study. J Thorac Cardiovasc Surg. 1997 Sep;114(3):347-53. doi: 10.1016/S0022-5223(97)70179-X.
PubMed 9305186Okada M, Yoshikawa K, Hatta T, Tsubota N. Is segmentectomy with lymph node assessment an alternative to lobectomy for non-small cell lung cancer of 2 cm or smaller? Ann Thorac Surg. 2001 Mar;71(3):956-60; discussion 961. doi: 10.1016/s0003-4975(00)02223-2.
PubMed 11269480
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer
- ClinicalTrials.gov ID
- NCT03185754
- Acronym / sponsor ID
- 201212107RIND
- Conditions
- Lung Cancer, Surgery
- Keywords
- lung cancer, surgery, lobectomy, sublobar resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jun 2017 (actual)
- 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.
A multi-center prospective randomized trial in Taiwan to investigate whether sublobar resection, as compared to lobectomy, can offer equivalent clinical results to treat early non-small cell lung cancer.
Detailed description
Background: Lung cancer has become an important disease threatening the public health world-wide. Surgical resection is the standard of care for treating non-small cell lung cancer in early stage. For decades, pulmonary lobectomy with lymph node dissection remains the gold standard of surgical approach. Pulmonary sublobar resection with pulmonary wedge resection or segmentectomy was reserved for the patients with high surgical risk, who were unsuitable for radical surgical resection. Pulmonary sublobar resection for tumor less than three centimeter was demonstrated to associated with higher risk of tumor recurrence or worsening survival outcome as compared to that done by lobectomy. 1 However, these data was which was not necessarily applicable to patients with early lung cancer with tumor of smaller size which was more frequently detected with the health screening test by CT scan in general population now. Although several retrospective studies has demonstrated that sublobar resection can offer a similar survival outcome after surgery as compared to that done by standard lobectomy once the tumor was smaller than two centimeter 2, there is still no consensus about the role of sublobar resection for these small early lung cancer. In general, there are several factors associating with higher risk of local recurrence which should be avoided for sublobar resection, including resection margin less than 2 cm or less than the diameter of the tumor itself 3, more obvious speculation in CT image or central location which makes it difficult to obtain adequate resection margin 4,5. Therefore, sublobar resection should be applied to the patients of early lung cancer when two cm of resection margin is achievable. The central location , obvious tumor infiltration in image study or presence of lymph node metastasis should be also avoided.
Patients and methods: The study will include surgical patients from six medical centers in Taiwan. All of the patients will receive complete study about the surgical risk and tumor staging before surgery. The patients will receive general anesthesia and pulmonary resection as the standard procedures including division of pulmonary vessels and bronchus. Either VATS (Video-assisted thoracoscopic surgery) or open surgery is acceptable for the surgical approaches. The patients will be randomly assigned to lobectomy and sublobar resection groups. Two cm of resection margin will be obtained in each patient in the sublobar resection group by wedge resection or segmentectomy. Standard lymph node dissection including the pulmonary hilum and mediastinum will be done in both groups of patients. For suspicious of pulmonary hilum or mediastinal lymph node metastasis, frozen pathological examination will be requested.
Post operative care and follow-up: The patients will be transferred to intensive care unit or surgical recovery room after surgery. Medication for pain control and postoperative rehabilitation education will be given to each patient after surgery. The chest tube will be removed after daily discharge less than 100 to 200 ml without air-leakage, adequate lung expansion noted in chest X ray imaging. The patient will be discharged from the hospital one or two days after removal of the chest tube. Whole body bone scan and CT scan will be given in every 6 months at least after surgery for postoperative follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early phase lung cancer | Experimental | Procedure: Sublobar resection, Procedure: lobectomysublobar resection and lobectomy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Early non-small cell lung cancer (stage Ia) with diameter of two centimeters or less.
- Tumor locating at the peripheral lung parenchyma (outer one third in CT imaging).
- No suspected hilar or mediastinal lymph nodes metastasis in the CT or PET imaging study.
Key exclusion criteria (6 listed)
- Tumor diameter more than 2 centimeter
- Hilar or mediastinal lymphnode metastasis by the cancer.
- Patients received previous surgery in the ipsi-lateral lung
- Lung tumor locating in the central lung parenchyma unable to obtain curative resection by sublobar resection.
- Patients with poor cardiopulmonary function unsuitable for receiving surgical resection.
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 |
|---|---|---|
| Sublobar resectionSublobar resection | Procedure or surgery | early phase lung cancer |
| lobectomylobectomy | Procedure or surgery | early phase lung cancer |
Primary outcome
Disease-free survival (DFS)
Time frame: 5 years
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
4 secondary outcomes
post-operative complication
Time frame: 3 months
Hospitalization time
Time frame: 3 months
Chest tube duration
Time frame: 3 months
post-operative pulmonary function
Time frame: 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Results publication: PubMed 7677489Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995 Sep;60(3):615-22; discussion 622-3. doi: 10.1016/0003-4975(95)00537-u.
- Results publication: PubMed 18261918Sienel W, Dango S, Kirschbaum A, Cucuruz B, Horth W, Stremmel C, Passlick B. Sublobar resections in stage IA non-small cell lung cancer: segmentectomies result in significantly better cancer-related survival than wedge resections. Eur J Cardiothorac Surg. 2008 Apr;33(4):728-34. doi: 10.1016/j.ejcts.2007.12.048. Epub 2008 Feb 7.
- Results publication: PubMed 9305186Kodama K, Doi O, Higashiyama M, Yokouchi H. Intentional limited resection for selected patients with T1 N0 M0 non-small-cell lung cancer: a single-institution study. J Thorac Cardiovasc Surg. 1997 Sep;114(3):347-53. doi: 10.1016/S0022-5223(97)70179-X.
- Results publication: PubMed 11269480Okada M, Yoshikawa K, Hatta T, Tsubota N. Is segmentectomy with lymph node assessment an alternative to lobectomy for non-small cell lung cancer of 2 cm or smaller? Ann Thorac Surg. 2001 Mar;71(3):956-60; discussion 961. doi: 10.1016/s0003-4975(00)02223-2.
- Individual participant dataSharing planned: No
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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.
Lee Jang-Ming principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sublobar resection and lobectomy in people with Lung Cancer and Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 6 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 5 Nov 2020. 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 Taiwan. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185754, which also lists 4 linked publications.
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 5 Nov 2020.