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

NCT04135664 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Chest Hospital

Phase

Phase 3

Started

2019-09-01

Last updated

2019-10-22

Condition(s) studied

Esophageal Cancer

Investigational drug(s) / intervention(s)

esophagectomychemoradiationactive surveillance

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

chemoradiation: concurrent chemotherapy and radiotherapy

active surveillance: No further adjuvant therapy

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

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.

Primary outcome measure(s)

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.

Trial sites (6)

Facility	City	Region	Status
The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	Active Not Recruiting
Changhai Hospital, The Second Military Medical University	Shanghai	China	Active Not Recruiting
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	China	Active Not Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai	China	Recruiting
Zhongshan Hospital, Fudan University	Shanghai	China	Active Not Recruiting
Tianjin Medical University Cancer Institute and Hospital	Tianjin	China	Active Not Recruiting

More Shanghai Chest Hospital trials in China

Infiltration Pattern of Locally Advanced ESCC Enrolling by invitation

GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy Starting soon

Electroacupuncture Plus 5-HT3 Receptor Inhibitor for PONV Prevention in High-Risk Patients Undergoing Thoracoscopic Lung Cancer Surgery Recruiting

Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in Persistent Atrial Fibrillation Starting soon

Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer Recruiting

Other trials for the same condition

Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma Recruiting

Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE） Recruiting

Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors Recruiting

Evaluation of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors Enrolling by invitation

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04135664 on ClinicalTrials.gov ↗ ← All trials in China