Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal Squamous Cell Carcinoma, Esophagectomy, Neoadjuvant therapy
Brief summary
Comparison of esophagectomy with Two-field Versus Three-field lymphadenectomy in locally advanced ESCC patients after neoadjuvant therapy
Detailed description
In locally advanced esophageal squamous cell carcinoma patients, neoadjuvant therapy has become a standard therapeutic strategy and been widely administered. Neoadjuvant therapy drastically reduces the metastatic lymph nodes rate as verified in numerous studies including CROSS (Netherlands), JCOG9907/1109 (Japan), NEOCRTEC5010 and CMISG1701 (China) trials, which entails a study to characterize the distribution of lymph node metastasis, and to identify the optimal extent of lymphadenectomy in ESCC patients who received neoadjuvant therapy. This study aims to clarify whether three-field (cervical-thoracic-abdominal) lymphadenectomy will improve survival over two-field (thoracic-abdominal) lymphadenectomy for ESCC patients after neoadjuvant therapy. An estimated 323 patients will be enrolled. Eligible patients will undergo right recurrent laryngeal nerve lymph node dissection (106recR), which will be subjected to intra-operative frozen resection pathological evaluation. If 106recR lymph node reports POSITIVE, patients will undergo esophagectomy with Three-Field lymphadenectomy (n=75). If 106recR lymph node reports NEGATIVE, patients will be randomized at 1:1 ratio into two groups: A) Esophagectomy with Two-Field lymphadenectomy (n=124) or B) Esophagectomy with Three-Field lymphadenectomy (n=124). Analyses will be done according to the intention-to-treat principle. The primary end point is overall survival (OS), calculated from the date of randomization to the date of death from any cause. Secondary end point is Disease-free survival. Other exploratory end points include tumor recurrence pattern, quality of life, peri-operative complications, and the correlation between metastases of 106recR and cervical lymph nodes.
Interventions
PROCEDURETwo-Field lymph node dissection
The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with Two-Field or Three-Field lymph node dissection.
PROCEDUREThree-Field lymph node dissection
The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with Two-Field or Three-Field lymph node dissection.
Sponsors
Baoji Central Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Suining Central Hospital
Jieyang People's Hospital
Second Affiliated Hospital of Nantong University
Taixing People's Hospital
Hebei Medical University Fourth Hospital
Suzhou Municipal Hospital
Fujian Provincial Hospital
Jining First People's Hospital
The General Hospital of Western Theater Command
Zhejiang Cancer Hospital
Shanghai Chest Hospital
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Squamous cell carcinoma was diagnosed by the pathological type of gastroscopic biopsy; 2. The primary tumor is located in the thoracic, and the primary site of esophageal cancer is determined by the location of the esophagus where the upper edge of the mass is located (upper thoracic esophagus: from the entrance of the thoracic cavity, down to the level of the lower edge of the azygos vein arch, 20 cm from the incisors to the endoscopy \<25 cm; middle thoracic esophagus: from the lower border of the azygos vein arch, down to the level of the inferior pulmonary vein, 25 cm to 30 cm from the incisors on endoscopy; lower thoracic esophagus: from the level of the inferior pulmonary veins, down to the stomach, internal Endoscopy 30 cm to 40 cm from the incisors); 3. According to the above examinations, patients with cII-III stage esophageal squamous cell carcinoma after received neoadjuvant therapy (including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant immunotherapy or neoadjuvant immunotherapy combined with chemotherapy, etc.), preoperative clinical evaluation was performed. Patients with esophageal cancer of clinical stage ycT1b-3N0-1M0 who can undergo surgical resection (enhanced chest and abdomen CT, cervical lymph node ultrasound and other methods to evaluate whether the tumor has obvious external invasion, whether the mediastinal lymph nodes have obvious enlargement, whether there are distant organs metastases or not); if the primary tumor is suspected to be T4b, multiple mediastinal lymph node metastases, or remote metastases, etc., whole-body PET-CT, endoscopic ultrasonography (EUS) (optional) and other tests are performed to further clarify the clinical stage), and there is no large cervical lymph nodes (\<0.8 cm in short-axis diameter of lymph nodes by CT or ultrasonography, or \<0.65 in short- and long-axis diameters of lymph nodes) 4. Age ≥18 years old, ≤75 years old, physical condition score ECOG 0～1, expected survival period ≥12 months; 5. No major organ dysfunction, blood routine, lung, liver, kidney and heart functions were basically normal. Laboratory test indicators must meet the following requirements: Blood: white blood cells\>4.0×109/L, absolute count of neutrophils (ANC)≥2.0×109/L, platelet count\>100×109/L, hemoglobin\>90g/L Pulmonary function: FEV1≥1.2L, FEV1%≥50%, and DLCO≥50%; usually in elderly patients (over 60 years old), lung function is assessed by the stair climbing test; Liver function: serum bilirubin less than 1.5 times the maximum normal value; ALT and AST less than 1.5 times the maximum normal value. Renal function: Serum creatinine (SCr)≤120µmol/L, creatinine clearance rate (CCr)≥60ml/min; 6. Be able to understand the situation of this research and sign the informed consent. 7. No gender selection 8. No healthy subjects are accepted
Exclusion criteria
1. Enhanced CT of chest and abdomen, ultrasound of cervical lymph nodes, whole body PET-CT (optional) or EBUS (optional), etc. The clinical staging was determined by imaging examination as (AJCC/UICC8th Edition) T4b unresectable (can be treated by two judged by a senior thoracic surgeon) \[52\], multiple lymphadenopathy (estimated lymph node metastasis ≥ 3), multiple sites Patients with enlarged lymph nodes (estimated number of lymph node metastases ≥ 2) or distant metastasis (M1); patients with enlarged lymph nodes Cervical lymph nodes (the short-axis diameter of lymph nodes determined by CT or ultrasonography is \> 0.8 cm, or the short and long diameters of lymph nodes are \> 0.8 cm. 0.65); 2. Those who have received or are receiving other chemotherapy, radiotherapy or targeted therapy; 3. The pathology of gastroscopy is non-squamous cell carcinoma; 4. Have other tumors in the past (except for those who have suffered from cervical carcinoma in situ or local skin basal cell carcinoma and have been cured); Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival(OS) | Up to the date of death of any causes since the date of surgery, up to 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | Up to the date of death of any causes since the date of surgery, up to 36 months | Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs) |
Countries
China
Contacts
Primary ContactJun Yin
Backup ContactLijie Tan
Outcome results
None listed