Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
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
1 other identifier
interventional
176
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2019
Longer than P75 for phase_3
6 active sites
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
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
October 22, 2019
August 1, 2019
8.3 years
October 9, 2019
October 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
5-year overall survival rate
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 Outcomes (5)
3-year overall survival rate
3 years after enrollment day
3-year relapse free survival rate
3 years after enrollment day
5-year relapse free survival rate
5 years after enrollment day
Quality of life differences (EORTC QLQ-C30)
1st, 3rd, 6th, 12th and 24th month after enrollment
Quality of life differences (EORTC QLQ-OES18)
1st, 3rd, 6th, 12th and 24th month after enrollment
Study Arms (3)
Patients undergoing adjuvant esophagectomy
ACTIVE COMPARATORPatients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant esophagectomy.
Patients undergoing adjuvant chemoradiation
EXPERIMENTALPatients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant chemoradiation.
Prospective registry of patients that cannot be randomized
ACTIVE COMPARATORPatients 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.
Interventions
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
concurrent chemotherapy and radiotherapy
No further adjuvant therapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, JX 791, China
Changhai Hospital, The Second Military Medical University
Shanghai, SH 21, China
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, SH 21, China
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, SH 21, China
Zhongshan Hospital, Fudan University
Shanghai, SH 21, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Related Publications (2)
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.
PMID: 38876135DERIVEDYang 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.
PMID: 32611448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhigang Li, MD, PhD
Shanghai Chest Hospital of Shanghai Jiao Tong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Department of Esophageal Surgery, Deputy of Department of Thoracic Surgery
Study Record Dates
First Submitted
October 9, 2019
First Posted
October 22, 2019
Study Start
September 1, 2019
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
October 22, 2019
Record last verified: 2019-08