Esophageal Cancer
Conditions
Keywords
esophagectomy, chemoradiation, esophageal cancer, endoscopic submucosal dissection
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).
Detailed description
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.
Interventions
PROCEDUREesophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
COMBINATION_PRODUCTchemoradiation
concurrent chemotherapy and radiotherapy
OTHERactive surveillance
No further adjuvant therapy
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival rate | 3 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. |
| 3-year relapse free survival rate | 3 years after enrollment day | 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-year relapse free survival rate | 5 years after enrollment day | 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. |
| Quality of life differences (EORTC QLQ-C30) | 1st, 3rd, 6th, 12th and 24th month after enrollment | 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. |
| Quality of life differences (EORTC QLQ-OES18) | 1st, 3rd, 6th, 12th and 24th month after enrollment | 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. |
Countries
China
Contacts
Primary ContactZhigang Li, MD
Backup ContactXiaobin Zhang, MD
Outcome results
None listed