Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
NCT ID: NCT04135664
Last Updated: 2019-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
176 participants
INTERVENTIONAL
2019-09-01
2027-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
esophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
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.
chemoradiation
concurrent chemotherapy and radiotherapy
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.
esophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
chemoradiation
concurrent chemotherapy and radiotherapy
active surveillance
No further adjuvant therapy
Interventions
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esophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
chemoradiation
concurrent chemotherapy and radiotherapy
active surveillance
No further adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Zhigang Li
Chief of Department of Esophageal Surgery, Deputy of Department of Thoracic Surgery
Principal Investigators
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Zhigang Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital of Shanghai Jiao Tong University
Locations
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Changhai Hospital, The Second Military Medical University
Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, , China
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, , China
Zhongshan Hospital, Fudan University
Shanghai, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Al-Batran SE, Koch C. Neoadjuvant therapy for oesophageal cancer: refining the armamentarium. Lancet. 2024 Jul 6;404(10447):5-7. doi: 10.1016/S0140-6736(24)01084-5. Epub 2024 Jun 11. No abstract available.
Yang Y, Su Y, Zhang X, Liu J, Zhang H, Li B, Hua R, Tan L, Chen H, Li Z. Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial). Trials. 2020 Jul 1;21(1):603. doi: 10.1186/s13063-020-04461-5.
Other Identifiers
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Chest201908
Identifier Type: -
Identifier Source: org_study_id
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