Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

October 20, 2019 updated by: Zhigang Li, Shanghai Chest Hospital

Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial

The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.

The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.

The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.

The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.

The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.

Study Type

Interventional

Enrollment (Anticipated)

176

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Xiaobin Zhang, MD
  • Phone Number: 18516302162 18516302162
  • Email: zxb5212@163.com

Study Locations

  • China
      • Shanghai, China, SH 21
        • Active, not recruiting
        • ChangHai Hospital, The Second Military Medical University
      • Shanghai, China, SH 21
        • Active, not recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
      • Shanghai, China, SH 21
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiao Tong University
        • Contact:
      • Shanghai, China, SH 21
        • Active, not recruiting
        • Zhongshan Hospital, Fudan University
      • Tianjin, China
        • Active, not recruiting
        • Tianjin Medical University Cancer Institute and Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, JX 791
        • Active, not recruiting
        • The First Affiliated Hospital of NanChang University

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy proven with esophageal squamous cell cancer.
  • Clinical N0 stage diagnosed by imaging examinations.
  • Pathological T1b stage confirmed by endoscopic submucosal dissection.
  • Age: 18-75.
  • Tumor located at the thorax.
  • Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Written informed consent.

Exclusion Criteria:

  • Prior intervention treatment before endoscopic submucosal resection.
  • Inability to accept any treatment component.
  • Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
  • Distant metastasis.
  • The circumference of the lumen over 3/4
  • Main tumor size > 5cm assessed by endoscopy
  • Inability to understand the 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients undergoing adjuvant esophagectomy

Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma.

Patients randomized into undergoing adjvant esophagectomy.
Procedure: esophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
Experimental: Patients undergoing adjuvant chemoradiation

Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma.

Patients randomized into undergoing adjvant chemoradiation.
Combination product: chemoradiation
concurrent chemotherapy and radiotherapy
Active Comparator: Prospective registry of patients that cannot be randomized

Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma.

Patients cannot be randomized into undergoing adjvant esophagectomy or chemoradiaton.

This arm includes patients undergoing adjuvant esophagectomy; adjuvant chemoradiation and active surveillance.
Procedure: esophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
Combination product: chemoradiation
concurrent chemotherapy and radiotherapy
Other: active surveillance
No further adjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival rate
Time Frame: 5 years after enrollment day
The overall survival is defined as days from date of randomization to death from any cause, and cencored at the last day of follow up when patients are alive.
5 years after enrollment day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival rate
Time Frame: 3 years after enrollment day
The overall survival is defined as days from date of randomization to death from any cause, and cencored at the last day of follow up when patients are alive.
3 years after enrollment day
3-year relapse free survival rate
Time Frame: 3 years after enrollment day
The relapse free survival is defined as days from date of randomization until the date of tumor progression or the date of death causing of any reasons, and cencored at the last day of follow up when patients are alive.
3 years after enrollment day
5-year relapse free survival rate
Time Frame: 5 years after enrollment day
The relapse free survival is defined as days from date of randomization until the date of tumor progression or the date of death causing of any reasons, and cencored at the last day of follow up when patients are alive.
5 years after enrollment day
Quality of life differences (EORTC QLQ-C30)
Time Frame: 1st, 3rd, 6th, 12th and 24th month after enrollment
The quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire. Patients will be invited to finish the questionnaire at the day of recruitment, 1st, 3rd, 6th, 12th and 24th month after randomization.
1st, 3rd, 6th, 12th and 24th month after enrollment
Quality of life differences (EORTC QLQ-OES18)
Time Frame: 1st, 3rd, 6th, 12th and 24th month after enrollment
The quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-OES18) questionnaire. Patients will be invited to finish the questionnaire at the day of recruitment, 1st, 3rd, 6th, 12th and 24th month after randomization.
1st, 3rd, 6th, 12th and 24th month after enrollment

Collaborators and Investigators

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

Sponsor

Shanghai Chest Hospital

Investigators

  • Principal Investigator: Zhigang Li, MD, PhD, Shanghai Chest Hospital, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2019

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 20, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chest201908

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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