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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing adjuvant esophagectomy | Active Comparator | Patients 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 | Experimental | Patients 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 Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esophagectomy | Procedure | esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 3-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. | 3 years after enrollment day |
| 3-year relapse free survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhigang Li, MD | Contact | 18960619260 | 18960619260 | dr_lizhigang@163.com |
| Xiaobin Zhang, MD | Contact | 18516302162 | 18516302162 | zxb5212@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhigang Li, MD, PhD | Shanghai Chest Hospital of Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanchang University | Active, not recruiting | Nanchang | Jiangxi | JX 791 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38876135 | Derived | 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. | |
| 32611448 | Derived | 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| D059248 | Chemoradiotherapy |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| chemoradiation | Combination Product | concurrent chemotherapy and radiotherapy |
|
| active surveillance | Other | No further adjuvant therapy |
|
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 | 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) | 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) | 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 |
| Changhai Hospital, The Second Military Medical University |
| Active, not recruiting |
| Shanghai |
| SH 21 |
| China |
| Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine | Active, not recruiting | Shanghai | SH 21 | China |
| Shanghai Chest Hospital, Shanghai Jiao Tong University | Recruiting | Shanghai | SH 21 | China |
|
| Zhongshan Hospital, Fudan University | Active, not recruiting | Shanghai | SH 21 | China |
| Tianjin Medical University Cancer Institute and Hospital | Active, not recruiting | Tianjin | China |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |