Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135664
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Zhigang Li, Shanghai Chest Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: esophagectomy Combination Product: chemoradiation Other: active surveillance Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2027
Estimated Study Completion Date : December 1, 2027

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135664


Contacts
Layout table for location contacts
Contact: Zhigang Li, MD 18960619260 ext 18960619260 dr_lizhigang@163.com
Contact: Xiaobin Zhang, MD 18516302162 ext 18516302162 zxb5212@163.com

Locations
Layout table for location information
China, Jiangxi
The First Affiliated Hospital of Nanchang University Active, not recruiting
Nanchang, Jiangxi, China, JX 791
China
Changhai Hospital, The Second Military Medical University Active, not recruiting
Shanghai, China, SH 21
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine Active, not recruiting
Shanghai, China, SH 21
Shanghai Chest Hospital, Shanghai Jiao Tong University Recruiting
Shanghai, China, SH 21
Contact: Zhigang Li, Doctor    86-18930619260 ext 18960619260    dr_lizhigang@163.com   
Zhongshan Hospital, Fudan University Active, not recruiting
Shanghai, China, SH 21
Tianjin Medical University Cancer Institute and Hospital Active, not recruiting
Tianjin, China
Sponsors and Collaborators
Shanghai Chest Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhigang Li, MD, PhD Shanghai Chest Hospital, Shanghai Jiao Tong University

Layout table for additonal information
Responsible Party: Zhigang Li, Chief of Department of Esophageal Surgery, Deputy of Department of Thoracic Surgery, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT04135664    
Other Study ID Numbers: Chest201908
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhigang Li, Shanghai Chest Hospital:
esophagectomy
chemoradiation
esophageal cancer
endoscopic submucosal dissection
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases