Clinical trial NCT02448953: Two-field Versus Three-field Lymphadenectomy in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement
Official title: Comparison of Lymph Node Dissection Results and Prognosis in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement: Two-field Versus Three-field Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: Without cervical lymph node involvement
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Peking University Cancer Hospital & Institute
name: Henan Cancer Hospital
name: Hebei Medical University Fourth Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Fujian Cancer Hospital
name: Liaoning Cancer Hospital & Institute
name: Zhejiang Cancer Hospital
name: Tongji Hospital
name: Tang-Du Hospital
name: Shanghai Chest Hospital
First posted: 2015-05-20
Enrollment: 786
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: The purpose of this study is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma patients without cervical lymph node involvement by preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.

Detailed description: Esophageal carcinoma is a prevalent and aggressive malignant disease with poor prognosis in China. Complete surgical resection with systemic lymph node dissection remains the most effective treatment method for this malignancy. Although tree-field lymph node dissection was reported to be effective in improving long-term survival in Japan,there is no enough evidences yet to demonstrate that three field lymph node dissection is superior to two field lymph node dissection in reducing postoperative recurrence and improving long-term survival. In this study, the dissection of lymph node adjacent to the right recurrent laryngeal nerve would be performed and examined routinely by intraoperative frozen-section. If the lymph node is positive, three field lymph node dissection(Cervical-thoracic-upper abdominal lymphadenectomy) will be performed, if negative, the patients will be randomly assigned either to three-field lymphadenectomy group or two-field lymphadenectomy group. The purpose of this large scale multi-center trial is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma without cervical lymph node involvement treated by three-field lymphadenectomy or two-field lymphadenectomy and clarify whether the lymph node along the right recurrent laryngeal nerve could be taken as sentinel lymph node indicating neck lymph node metastasis and necessity of three-field lymphadenectomy.

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically confirmed squamous cell esophageal cancer, without any previous anti-tumor therapy;
2. Preoperative clinical TNM stage：cT1b-3N0-1M0;
3. Adequate cardiopulmonary, liver, brain and kidney functions for esophagectomy either via right thoracotomy or VATS;
4. No evidence of suspicious neck lymph node metastasis (LN short diameter \< 0.8cm or LN short/long diameter \<0.65 by cervical CT and/or ultrasound);
5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail

Exclusion Criteria:

1. Previous use of anti-cancer therapy;
2. Preoperative clinical TNM stage: N2-3 or M1;
3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
4. Previous malignancy history.
5. Suspicious neck lymph node metastasis (LN short diameter ≧0.8cm or LN short/long diameter ≧0.65 by cervical CT and/or ultrasound);
6. 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: Locoregional recurrence
timeFrame: 5 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:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jie He, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: