NCT02448953

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
786

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

May 8, 2015

Last Update Submit

May 17, 2015

Conditions

Esophageal Cancer

Keywords

Without cervical lymph node involvement

Outcome Measures

Primary Outcomes (1)

  • Long term survival

    5 years

Secondary Outcomes (3)

  • Disease free survival

    5 years

  • Locoregional recurrence

    5 years

  • Postoperative complications

    3 years

Study Arms (2)

negative lymph node

ACTIVE COMPARATOR

lymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination

Procedure: Two-field lymphadenectomyProcedure: Three-field lymphadenectomy

positive lymph node

ACTIVE COMPARATOR

lymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination

Procedure: Three-field lymphadenectomy

Interventions

Two-field lymphadenectomyPROCEDURE

Thoracic-upper abdominal two-field lymphadenectomy

negative lymph node
Three-field lymphadenectomyPROCEDURE

Cervical-thoracic-upper abdominal three-field completely lymphadenectomy

negative lymph nodepositive lymph node

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed squamous cell esophageal cancer, without any previous anti-tumor therapy;
  • Preoperative clinical TNM stage：cT1b-3N0-1M0;
  • Adequate cardiopulmonary, liver, brain and kidney functions for esophagectomy either via right thoracotomy or VATS;
  • 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);
  • Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail

You may not qualify if:

  • Previous use of anti-cancer therapy;
  • Preoperative clinical TNM stage: N2-3 or M1;
  • Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
  • Previous malignancy history.
  • Suspicious neck lymph node metastasis (LN short diameter ≧0.8cm or LN short/long diameter ≧0.65 by cervical CT and/or ultrasound);
  • Unwilling to participate the clinical trial and refuse to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

  • Mao Y, Liu S, Han Y, Guo S, Chen C, Gao S, Hao A, Duan H, Fang W, Zhang R, Yu Z, Fu X, Li X, Wang Q, Tan L, Li Z, Li Y, Zhang Z, Wei W, Fang Y, Fu D, Wei X, Yuan L, Muhammad S, He J. Three-field vs two-field lymphadenectomy in thoracic ESCC patients: a multicenter randomized study (NST 1503). J Natl Cancer Cent. 2025 Jan 14;5(2):203-211. doi: 10.1016/j.jncc.2025.01.002. eCollection 2025 Apr.

    PMID: 40265094DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Jie He, MD,PhD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousheng Mao, MD

CONTACT

8610-87787138maoysherx@126.com

Zhirong Zhang, MD

CONTACT

8610-87788798zhangzr@cicams.ac.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
president

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 20, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2019

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CN(1)