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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
concurrent chemotherapy and radiotherapy
No further adjuvant therapy
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
ACTIVE_NOT_RECRUITINGChanghai Hospital, The Second Military Medical University
Shanghai, China
ACTIVE_NOT_RECRUITINGRuijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, China
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.
Time frame: 5 years after enrollment day
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.
Time frame: 3 years after enrollment day
3-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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, China
ACTIVE_NOT_RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, China
ACTIVE_NOT_RECRUITINGTime frame: 1st, 3rd, 6th, 12th and 24th month after enrollment