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This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.
Lobectomy has long been considered the standard procedure for early-stage lung cancer, and minimally invasive techniques have been demonstrated to be associated with superior outcomes compared with lobectomy by thoracotomy. the us of segmentectomy is under investigation for selected patients with small tumors, and the use of minimally invasive strategies is applicable as well.
This nationwide, multicenter, prospective, randomized open phase III study of cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy versus Lobectomy for stage IA non-small cell lung cancer (NSCLC) patients with Lung adenocarcinoma in situ or with microinvasion, is aiming to evaluate the relapse free survival and 5 year overall survival (OS) rate of two types of surgery. Patients are randomized to 1 of 2 treatment arms.
Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| segmentectomy | Experimental | Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy |
|
| Lobectomy | Active Comparator | Patients undergo cVATS lobectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patients undergo cVATS segmentectomy | Procedure |
| ||
| Patients undergo cVATS lobectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival | Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy. | From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year survival rate | Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy | participants are followed until death or up to 5 years |
| postoperative complication |
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Inclusion Criteria:
Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm in maximal diameter, no lymph node metastasis, FEV1%>50% (FEV1: Forced Expiratory Volume in 1 second);
Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solid areas < 0.5cm);
Follow-up duration last 3 months or more, HRCT (HRCT: high-resolution computed tomography) lesion maximum diameter was measured three times and took the average, meet the criteria of clinical surgical indications;
Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or with microinvasion;
No prior ipsilateral thoracotomy;
No prior anti-neoplastic therapy;
EOCG Performance status 0-2;
Sufficient organ functions;
Written informed consent.
Exclusion Criteria:
Active bacterial or fungous infection;
Simultaneous or prior (within the past 5 years) other malignant disease;
Interstitial pneumonitis, pulmonary fibrosis, or severe COPD (COPD: chronic obstructive pulmonary disease);
Abnormal Psychosis;
Uncontrollable diabetes mellitus;
History of severe cardiovascular disease;
Any condition which, in the opinion of the investigator might interfere with the evaluation of the objective.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxing He, MD | Contact | 83062810 | drjianxinghe@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianxing He, MD | First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21828029 | Background | Van Schil PE, Asamura H, Rusch VW, Mitsudomi T, Tsuboi M, Brambilla E, Travis WD. Surgical implications of the new IASLC/ATS/ERS adenocarcinoma classification. Eur Respir J. 2012 Feb;39(2):478-86. doi: 10.1183/09031936.00027511. Epub 2011 Aug 4. | |
| 7677489 | Background | 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. |
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| Procedure |
|
Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy
| 0 to 3 months postoperatively |
| pulmonary function | to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively | 6 months after surgery |
| Quality of Life | To evaluate the quality of life (QoL) of these patients, as measured by questionnaire of FACT-L (4th edition) and LCSS (Lung Cancer Symptom Scale) | 0 to 6 months postoperative |
| Nanfang Hospital |
| Guangzhou |
| Guangdong |
| China |
| First Affiliated Hospital Zhejiang University colleague of Medicine | Hangzhou | Zhejiang | China |
| China-Japan Friendship hospital | Beijing | China |
| Peking University Cancer Hospital | Beijing | China |
| Shanghai Chest Hospital | Shanghai | China |
| 19766789 | Background | Koike T, Togashi K, Shirato T, Sato S, Hirahara H, Sugawara M, Oguma F, Usuda H, Emura I. Limited resection for noninvasive bronchioloalveolar carcinoma diagnosed by intraoperative pathologic examination. Ann Thorac Surg. 2009 Oct;88(4):1106-11. doi: 10.1016/j.athoracsur.2009.06.051. |
| 19289625 | Background | Yan TD, Black D, Bannon PG, McCaughan BC. Systematic review and meta-analysis of randomized and nonrandomized trials on safety and efficacy of video-assisted thoracic surgery lobectomy for early-stage non-small-cell lung cancer. J Clin Oncol. 2009 May 20;27(15):2553-62. doi: 10.1200/JCO.2008.18.2733. Epub 2009 Mar 16. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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