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

May 17, 2015 updated by: Jie He, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
786

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer hospital, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: negative lymph node
lymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination
Procedure: Two-field lymphadenectomy
Thoracic-upper abdominal two-field lymphadenectomy
Procedure: Three-field lymphadenectomy
Cervical-thoracic-upper abdominal three-field completely lymphadenectomy
Active Comparator: positive lymph node
lymph node along the right recurrent laryngeal nerve should be confirmed negative by intraoperative frozen pathology examination
Procedure: Three-field lymphadenectomy
Cervical-thoracic-upper abdominal three-field completely lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Long term survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Disease free survival
Time Frame: 5 years
5 years
Postoperative complications
Time Frame: 3 years
3 years
Locoregional recurrence
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Cancer Hospital
Fujian Cancer Hospital
Henan Cancer Hospital
Tongji Hospital
Peking University Cancer Hospital & Institute
Shanghai Chest Hospital
Hebei Medical University Fourth Hospital
Tang-Du Hospital
Liaoning Tumor Hospital & Institute
Sichuan Cancer Hospital and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NKTRDP-2015BAI12B08-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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