- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185754
Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Jang-Ming Lee
- Phone Number: 65123 02-23123456
- Email: jangming@ntuh.gov.tw
-
Contact:
- Pei-Weng Yang
- Phone Number: 65071 02-23123456
- Email: jmlee@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: early phase lung cancer
sublobar resection and lobectomy
|
Sublobar resection
lobectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-operative complication
Time Frame: 3 months
|
defined as any deviation from the normal postoperative course
|
3 months
|
Hospitalization time
Time Frame: 3 months
|
the time interval from the day of surgery to discharge
|
3 months
|
Chest tube duration
Time Frame: 3 months
|
the time interval from the day of surgery to the day of chest tube removal
|
3 months
|
post-operative pulmonary function
Time Frame: 6, 12 and 24 months
|
the pulmonary function at 6, 12, and 24 months post-operation
|
6, 12 and 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain score
Time Frame: 1, 3, and 7 days
|
post-operative pain assessment during hospital stay
|
1, 3, and 7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lee Jang-Ming, National Taiwan University Hospital
Publications and helpful links
General 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.
- Sienel 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.
- Kodama 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.
- Okada 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201212107RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingCaregiver | Stage III Lung Cancer AJCC v7 | Stage I Lung Cancer AJCC v7 | Stage II Lung Cancer AJCC v7 | Stage IB Lung Cancer AJCC v7 | Stage IA Lung Cancer AJCC v7 | Stage IIA Lung Cancer AJCC v7 | Stage IIB Lung Cancer AJCC v7 | Stage IIIA Lung Cancer AJCC v7 | Stage IIIB Lung Cancer AJCC v7United States
-
Dana-Farber Cancer InstituteMedWaves, IncNot yet recruitingLung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung CancerUnited States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
University of California, San FranciscoMerck Sharp & Dohme LLCWithdrawnLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Head and Neck Carcinoma | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung... and other conditionsUnited States
Clinical Trials on Sublobar resection
-
Fudan UniversityRecruitingLung Adenocarcinoma | Frozen Section | Sublobar ResectionChina
-
Shanghai Zhongshan HospitalRenJi Hospital; Ruijin Hospital; Fujian Medical University Union Hospital; First... and other collaboratorsRecruitingCarcinoma, Non-Small-Cell LungChina
-
Mayo ClinicTerminatedLung NeoplasmsUnited States
-
Tongji HospitalLinkDoc Technology (Beijing) Co. Ltd.CompletedA Study to Evaluate Effectiveness of Sublobar Dissection in Patients With Non-small Cell Lung CancerNon-small Cell Lung CancerChina
-
Oslo University HospitalUniversity of Oslo; Helse Stavanger HF; Haukeland University Hospital; St. Olavs... and other collaboratorsRecruitingColorectal Cancer | Liver Metastases | Liver Metastasis Colon Cancer | Colorectal Neoplasms MalignantNorway
-
University of UlmTerminated
-
BUSQUETS, JULINot yet recruiting
-
Southwest Hospital, ChinaUnknown
-
Fudan UniversityUnknownLocal Recurrence of Malignant Tumor of Soft TissueChina
-
Fudan UniversityCompleted