Two-field Versus Three-field Lymphadenectomy in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448953
• Other study ID #: NKTRDP-2015BAI12B08-03
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2015
• Last updated: May 17, 2015
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Yousheng Mao, MD
• Phone: 8610-87787138
• Email: maoysherx[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 786
• Est. completion date: December 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Two-field lymphadenectomy
Thoracic-upper abdominal two-field lymphadenectomy
• Three-field lymphadenectomy
Cervical-thoracic-upper abdominal three-field completely lymphadenectomy

Locations

Country	Name	City	State
China	Cancer hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (11)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Beijing Cancer Hospital, Fujian Cancer Hospital, Hebei Medical University Fourth Hospital, Henan Cancer Hospital, Liaoning Tumor Hospital & Institute, Shanghai Chest Hospital, Sichuan Cancer Hospital and Research Institute, Tang-Du Hospital, Tongji Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term survival		5 years	Yes
Secondary	Disease free survival		5 years	Yes
Secondary	Locoregional recurrence		5 years	Yes
Secondary	Postoperative complications		3 years	Yes