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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 3

Conditions: Esophageal Cancer

Treatments: Procedure: esophagectomy; Combination Product: chemoradiation; Other: active surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT04135664

Chest201908

Details and patient eligibility

About

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).

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

176 participants in 3 patient groups

Patients undergoing adjuvant esophagectomy

Active Comparator group

Description:

Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant esophagectomy.

Treatment:

Procedure: esophagectomy

Patients undergoing adjuvant chemoradiation

Experimental group

Description:

Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant chemoradiation.

Treatment:

Combination Product: chemoradiation

Prospective registry of patients that cannot be randomized

Active Comparator group

Description:

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.

Treatment:

Procedure: esophagectomy

Combination Product: chemoradiation

Other: active surveillance