Clinical trial NCT02448979: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Peking University Cancer Hospital & Institute
name: Henan Cancer Hospital
name: Hebei Medical University Fourth Hospital
name: Harbin Medical University
name: Liaoning Cancer Hospital & Institute
name: Hunan Cancer Hospital
name: Sun Yat-sen University
name: Zhejiang Cancer Hospital
name: Tongji Hospital
First posted: 2015-05-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically proved squamous cell esophageal cancer without any previous anti-tumor therapy;
2. The preoperative clinical TNM stage: cT1b-3N0-1M0;
3. Adequate function of heart, lung, liver, brain and kidney, which can tolerate esophagectomy either through left or right thoracotomy;
4. Without any preoperative distant metastases confirmed by preoperative examination such as chest and abdominal CT, brain MRI and bone scan or PET-CT;
5. 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).
6. Willing to participate the clinical trial and sign informed consent before being enrolled into clinical trail.

Exclusion Criteria:

1. Non-squamous cell esophageal carcinoma or has any previous anti-cancer therapy before surgery;
2. The preoperative clinical TNM stage reaches: N2-3 or M1;
3. Inadequate cardiopulmonary, liver, brain and kidney function for tolerating the esophagectomy ;
4. Previous history of malignancy;
5. Unwilling to participate the clinical trial and refuse to sign informed consent

Primary outcomes:
measure: Long term survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 years
measure: Degree of lymph node dissection
timeFrame: 3 years
measure: Postoperative complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
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.