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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 6
- 主要终点
- 5-year overall survival rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven with esophageal squamous cell cancer.
- •Clinical N0 stage diagnosed by imaging examinations.
- •Pathological T1b stage confirmed by endoscopic submucosal dissection.
- •Tumor located at the thorax.
- •Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Written informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: esophagectomy (Procedure)
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.
干预措施: chemoradiation (Combination Product)
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.
干预措施: esophagectomy (Procedure)
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.
干预措施: chemoradiation (Combination Product)
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.
干预措施: active surveillance (Other)
结局指标
主要结局
5-year overall survival rate
时间窗: 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.
次要结局
- 3-year overall survival rate(3 years after enrollment day)
- Quality of life differences (EORTC QLQ-OES18)(1st, 3rd, 6th, 12th and 24th month after enrollment)
- 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)
研究者
Zhigang Li
Chief of Department of Esophageal Surgery, Deputy of Department of Thoracic Surgery
Shanghai Chest Hospital