Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135664
• Other study ID #: Chest201908
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2019
• Est. completion date: December 1, 2027

Study information

• Verified date: August 2019
• Source: Shanghai Chest Hospital
• Contact: Zhigang Li, MD
• Phone: 18960619260
• Email: dr_lizhigang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Cancer
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Procedure:
• esophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy

Combination Product:
• chemoradiation
concurrent chemotherapy and radiotherapy

Other:
• active surveillance
No further adjuvant therapy

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Changhai Hospital, The Second Military Medical University	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai
China	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	3 years after enrollment day
Secondary	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
Secondary	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
Secondary	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