Esophagectomy in Middle and Lower Thoracic Esophageal Cancer Patients Through Left Versus Right Transthoracic Approach
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Left thoracotomy
Right thoracotomy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically proved squamous cell esophageal cancer without any previous anti-tumor therapy;
- The preoperative clinical TNM stage: cT1b-3N0-1M0;
- Adequate function of heart, lung, liver, brain and kidney, which can tolerate esophagectomy either through left or right thoracotomy;
- Without any preoperative distant metastases confirmed by preoperative examination such as chest and abdominal CT, brain MRI and bone scan or PET-CT;
- No evidence showing suspicious upper mediastinal lymph node metastasis (short diameter of LN <0.8cm or shortest diameter / longest diameter <0.65) by the thoracic and abdominal CT and endoscopic ultrasonography(EUS).
- Willing to participate the clinical trial and sign informed consent before being enrolled into clinical trail.
Exclusion Criteria:
- Non-squamous cell esophageal carcinoma or has any previous anti-cancer therapy before surgery;
- The preoperative clinical TNM stage reaches: N2-3 or M1;
- Inadequate cardiopulmonary, liver, brain and kidney function for tolerating the esophagectomy ;
- Previous history of malignancy;
- Unwilling to participate the clinical trial and refuse to sign informed consent
Sites / Locations
- Cancer hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Left thoracotomy
Right thoracotomy
Arm Description
Esophagectomy through left side transthoracic approach, with esophagogastric anastomosis above aortic arch and two-field lymphadenectomy (thoracic and abdominal lymph node)
Esophagectomy through right side transthoracic approach, with esophagogastric anastomosis above azygos vain arch or on the top of chest cavity and two-field lymphadenectomy (thoracic and abdominal lymph node)
Outcomes
Primary Outcome Measures
Long term survival
Secondary Outcome Measures
Disease free survival
Degree of lymph node dissection
Postoperative complications
Full Information
NCT ID
NCT02448979
First Posted
May 8, 2015
Last Updated
May 17, 2015
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, Henan Cancer Hospital, Hebei Medical University Fourth Hospital, Harbin Medical University, Liaoning Tumor Hospital & Institute, Hunan Cancer Hospital, Sun Yat-sen University, Zhejiang Cancer Hospital, Tongji Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02448979
Brief Title
Esophagectomy in Middle and Lower Thoracic Esophageal Cancer Patients Through Left Versus Right Transthoracic Approach
Official Title
Randomized Control Study on Surgical Treatment for Middle and Lower Thoracic Esophageal Cancer Patients Without Upper Mediastinal Lymph Node Metastasis Through Left Versus Right Transthoracic Approach
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, Henan Cancer Hospital, Hebei Medical University Fourth Hospital, Harbin Medical University, Liaoning Tumor Hospital & Institute, Hunan Cancer Hospital, Sun Yat-sen University, Zhejiang Cancer Hospital, Tongji Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical resection remains the most effective method for this malignancy. Although different approaches have been studied for the surgical resection of thoracic esophageal cancer, little evidence has been achieved due to lack of large scale multicenter randomized trials with regard to this issue: whether left transthoracic approach or right transthoracic approach is the optimal surgical approach for treating middle and lower thoracic esophageal cancer without upper mediastinal lymph node metastasis. The purpose of this study is to compare the postoperative local recurrence rate and long-term outcome of esophagectomy through left and right transthoracic approach in the middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis.
Detailed Description
Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical resection remains the most effective method for this malignancy. As to the middle and lower thoracic esophageal cancer patients without upper mediastinal lymph node metastasis, the rational transthoracic approach either through right or left chest has not been clarified to date due to lack of large scale multicenter randomized trials. Although some randomized trials had been finished in single-center, there is no enough evidences that all lower and middle thoracic esophageal cancer patients should be surgically treated throuhg right chest approch. It is widely recognized that left thoracotomy approach(Sweet procedure) is not appropriate in the patients with upper mediastinal lymph node metastasis, because patients can benefit from the right thoracotomy approach, through which upper mediastinal lymph node can be dissected completely and may get a better long-term survival.Therefore,in this study, the enrolled patients are the middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis by CT and/or ultrasound, and 10 hospitals will participate this study. Through comparison in postoperative complications and long term outcomes as well as locoregional recurrence between the left and right apppoach, hopefully we can answer the question whether the right or left transthoracic procedure is the optimal approach for treating middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Left thoracotomy
Arm Type
Active Comparator
Arm Description
Esophagectomy through left side transthoracic approach, with esophagogastric anastomosis above aortic arch and two-field lymphadenectomy (thoracic and abdominal lymph node)
Arm Title
Right thoracotomy
Arm Type
Active Comparator
Arm Description
Esophagectomy through right side transthoracic approach, with esophagogastric anastomosis above azygos vain arch or on the top of chest cavity and two-field lymphadenectomy (thoracic and abdominal lymph node)
Intervention Type
Procedure
Intervention Name(s)
Left thoracotomy
Intervention Description
Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.
Intervention Type
Procedure
Intervention Name(s)
Right thoracotomy
Intervention Description
Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.
Primary Outcome Measure Information:
Title
Long term survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease free survival
Time Frame
5 years
Title
Degree of lymph node dissection
Time Frame
3 years
Title
Postoperative complications
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically proved squamous cell esophageal cancer without any previous anti-tumor therapy;
The preoperative clinical TNM stage: cT1b-3N0-1M0;
Adequate function of heart, lung, liver, brain and kidney, which can tolerate esophagectomy either through left or right thoracotomy;
Without any preoperative distant metastases confirmed by preoperative examination such as chest and abdominal CT, brain MRI and bone scan or PET-CT;
No evidence showing suspicious upper mediastinal lymph node metastasis (short diameter of LN <0.8cm or shortest diameter / longest diameter <0.65) by the thoracic and abdominal CT and endoscopic ultrasonography(EUS).
Willing to participate the clinical trial and sign informed consent before being enrolled into clinical trail.
Exclusion Criteria:
Non-squamous cell esophageal carcinoma or has any previous anti-cancer therapy before surgery;
The preoperative clinical TNM stage reaches: N2-3 or M1;
Inadequate cardiopulmonary, liver, brain and kidney function for tolerating the esophagectomy ;
Previous history of malignancy;
Unwilling to participate the clinical trial and refuse to sign informed consent
Facility Information:
Facility Name
Cancer hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yousheng Mao, MD
Phone
8610-87787138
Email
maoysherx@126.com
First Name & Middle Initial & Last Name & Degree
Zhirong Zhang, MD
Phone
8610-87788798
Email
zhangzr@cicams.ac.cn
First Name & Middle Initial & Last Name & Degree
Jie He, MD,PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
36111056
Citation
Mao YS, Gao SG, Li Y, Hao AL, Liu JF, Li XF, Rong TH, Fu JH, Ma JQ, Xu MQ, Zhang RQ, Xiao GM, Fu XN, Chen KN, Mao WM, Liu YY, Liu HX, Zhang ZR, Fang Y, Fu DH, Wei XD, Yuan LG, Muhammad S, Wei WQ, Chiu PW, Lloyd S, Schlottmann F, Meredith K, Pimiento JM, Gao YB, He J. Efficacy and safety of esophagectomy via left thoracic approach versus via right thoracic approach for middle and lower thoracic esophageal cancer: a multicenter randomized clinical trial (NST1501). Ann Transl Med. 2022 Aug;10(16):904. doi: 10.21037/atm-22-3810.
Results Reference
derived
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Esophagectomy in Middle and Lower Thoracic Esophageal Cancer Patients Through Left Versus Right Transthoracic Approach
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