Trial Title:
Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
NCT ID:
NCT06577792
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-small cell lung cancer
Lobectomy
Lymphadenectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Lobectomy-First
Description:
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform
lobectomy first, and then perform lymphadenectomy next.
Arm group label:
Lobectomy-First group
Intervention type:
Procedure
Intervention name:
Lymphadenectomy-First
Description:
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform
lymphadenectomy first, and then perform lobectomy next.
Arm group label:
Lymphadenectomy-First group
Summary:
During the surgery for non-small cell lung cancer (NSCLC), lymphadenectomy or lobectomy
are performed first, different surgeons have different choices. Oncology textbooks
require dissecting distant lymph nodes (LNs) first and then dissecting nearby LNs.
According to this requirement, thoracic surgeons should first perform lymphadenectomy and
then lobectomy. Unfortunately, there is no high-level evidence to prove which surgical
sequence is more beneficial to the long-term survival of NSCLC patients. In this
multi-center randomized controlled trial (RCT), patients with stage I-II NSCLC were
enrolled as the research object to determine which surgical sequence
(lymphadenectomy-first vs. lobectomy-first) is better for the short-term and long-term
outcomes in NSCLC patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age from 18 to 80 years old;
2. The first clinical diagnosis before surgery was non-small cell lung cancer,
including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other
unknown types;
3. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5 cm and short
diameter of mediastinal lymph node <= 1cm in thin layer computed tomography (CT);
4. The patient's physical condition is able to tolerate lobectomy: (1) Goldman index
0-1; (2) Predicted forced expiratory volume in 1s (FEV1) >= 40% and diffusing
capacity of the lung for carbon monoxide (DLCO) >= 40%; (3) Total bilirubin <= 1.5
upper limit of normal; (4) Alanine aminotransferase (ALT)/Aspartate aminotransferase
(AST) <= 2.5 upper limit of normal; (5) Creatinine <= 1.25 upper limit of normal and
creatinine clearance rate (CCr) >= 60 ml/min;
5. Performance status of Eastern Cooperative Oncology Group (ECOG) = 0-1;
6. All relevant examinations were completed within 28 days before the operation;
7. Patients who understand this study and have signed an approved Informed Consent.
Exclusion Criteria:
1. Patients who have undergone anti-tumor therapy (radiotherapy, chemotherapy, targeted
therapy, immunotherapy) before surgery;
2. Patients with previous medical history of other malignant tumors or combined with
second primary cancer at the time of enrollment;
3. Patients who meet all of the following criteria are eligible for sublobar resection
(segment/wedge resection): (1) Ground glass opacity (GGO) with a solid component <=
50%; (2) The largest diameter of nodule is <= 2 cm; (3) The nodule is located in the
outer third of the lung field;
4. Patients with preoperative diagnosis of pure GGO;
5. Patients with previous medical history of unilateral thoracotomy;
6. Women who are pregnant or breastfeeding;
7. Patients with active bacterial or fungal infection that is difficult to control;
8. Patients with serious psychosis;
9. Patients with a history of severe heart disease, heart failure, myocardial
infarction or angina pectoris in the past 6 months.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Qiu, M.D.
Email:
qiubin@cicams.ac.cn
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang-Bo Lin, M.D.
Email:
135279779@qq.com
Facility:
Name:
Fujian Provincial Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen-Shu Chen, M.D.
Email:
doctorcws@163.com
Facility:
Name:
Gansu Provincial Hospital
Address:
City:
Lanzhou
Zip:
730013
Country:
China
Status:
Recruiting
Contact:
Last name:
Yun-Jiu Gou, M.D.
Email:
gouyunjiu@163.com
Facility:
Name:
Dongguan People's Hospital
Address:
City:
Dongguan
Zip:
523059
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Du, M.D.
Email:
duwei1227@sina.com
Facility:
Name:
First People's Hospital of Foshan
Address:
City:
Foshan
Zip:
528000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei-Quan Gu, M.D.
Email:
gwquan@fsyyy.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao-Xian Yang, M.D.
Phone:
+86-020-87343628
Email:
yanghx@sysucc.org.cn
Contact backup:
Last name:
Mu-Zi Yang, M.D.
Phone:
+86-020-87341456
Email:
yangmz@sysucc.org.cn
Investigator:
Last name:
Hao-Xian Yang, M.D.
Email:
Principal Investigator
Facility:
Name:
First Affiliated Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510062
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chun-Hua Su, M.D.
Email:
kitten_sch@139.com
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Gui-Bin Qiao, M.D.
Email:
guibinqiao@126.com
Facility:
Name:
First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Zip:
510632
Country:
China
Status:
Recruiting
Contact:
Last name:
Song-Wang Cai, M.D.
Email:
caisongwang@jnu.edu.cn
Facility:
Name:
Sixth Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510655
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hong-Ying Liao, M.D.
Email:
liaohy2@mail.sysu.edu.cn
Facility:
Name:
Shenzhen People's Hospital
Address:
City:
Shenzhen
Zip:
518020
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guang-Suo Wang, M.D.
Email:
908611104@qq.com
Facility:
Name:
Hebei Medical University Fourth Hospital
Address:
City:
Shijia Zhuang
Zip:
050011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lei Wang, M.D.
Email:
Yuankundu@163.com
Facility:
Name:
Wuhan TongJi Hospital
Address:
City:
Wuhan
Zip:
430014
Country:
China
Status:
Recruiting
Contact:
Last name:
Ni Zhang, M.D.
Email:
nizhang@tjh.tjmu.edu.cn
Facility:
Name:
Wuhan Union Hospital, China
Address:
City:
Wuhan
Zip:
430090
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yong-De Liao, M.D.
Email:
liaotjxw@126.com
Facility:
Name:
Jiangsu Cancer Institute & Hospital
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Li, M.D.
Email:
liming750523@163.com
Facility:
Name:
The General Hospital of Eastern Theater Command
Address:
City:
Nanjing
Zip:
210016
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Yi, M.D.
Email:
njyijun@163.com
Facility:
Name:
The First Affiliated Hospital with Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Wang, M.D.
Email:
wangwei⁃doctor@163.com
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221132
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Zhang, M.D.
Email:
583737388@qq.com
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ben-Tong Yu, M.D.
Email:
yubentong@126.com
Facility:
Name:
Tang-Du Hospital
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiao-Long Yan, M.D.
Email:
yanxiaolong@fmmu.edu.cn
Facility:
Name:
Shaanxi Provincial Cancer Hospital
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guang-Yan Lei, M.D.
Email:
Lei-g-y@163.com
Facility:
Name:
Shandong Provincial Hospital
Address:
City:
Jinan
Zip:
250022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhong-Min Peng, M.D.
Email:
pengzhm@163.com
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266075
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wen-Jie Jiao, M.D.
Email:
jiaowj@qduhospital.cn
Facility:
Name:
RenJi Hospital
Address:
City:
Shanghai
Zip:
200001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiao-Zhe Qian, M.D.
Email:
qianxiaozhe@renji.com
Facility:
Name:
Shanghai Changzheng Hospital
Address:
City:
Shanghai
Zip:
201209
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Tang, M.D.
Email:
tanghua999@smmu.edu.cn
Facility:
Name:
Sichuan Cancer Hospital and Research Institute
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Xue-Feng Leng, M.D.
Email:
leng724@163.com
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yun Wang, M.D.
Email:
2237454336@qq.com
Contact backup:
Last name:
Jian-Dong Mei, M.D.
Email:
jiandongmei@aliyun.com
Facility:
Name:
Suining Central Hospital
Address:
City:
Suining
Zip:
629099
Country:
China
Status:
Recruiting
Contact:
Last name:
Hai-Ning Zhou, M.D.
Email:
haining_zhou@zmu.edu.cn
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian You, M.D.
Email:
youjiancn@126.com
Facility:
Name:
Tianjin Chest Hospital
Address:
City:
Tianjin
Zip:
300222
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Da-Qiang Sun, M.D.
Email:
datanju123456@163.com
Facility:
Name:
First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Zip:
650032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiao-Bo Chen, M.D.
Email:
chenxiaobo0416@163.com
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Zip:
315040
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Da-Wei Zheng, M.D.
Email:
13429295441@qq.com
Start date:
August 16, 2023
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Jinan University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Suining Central Hospital
Agency class:
Other
Collaborator:
Agency:
Ningbo Medical Center Lihuili Hospital
Agency class:
Other
Collaborator:
Agency:
Shanxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Xuzhou Medical University
Agency class:
Other
Collaborator:
Agency:
The General Hospital of Eastern Theater Command
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Kunming Medical University
Agency class:
Other
Collaborator:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Chest Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Shenzhen People's Hospital
Agency class:
Other
Collaborator:
Agency:
Tang-Du Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Gansu Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Wuhan TongJi Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
Jiangsu Cancer Institute & Hospital
Agency class:
Other
Collaborator:
Agency:
Dongguan People's Hospital
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Foshan
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06577792
https://www.chictr.org.cn/bin/project/edit?pid=178449
