Comparing surgery and radiation for early-stage esophageal cancer

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

This study is testing whether surgery or radiation works better for people with early-stage esophageal cancer to help them live longer and have a better quality of life.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 6 sites (Nanchang, Jiangxi and 5 other locations)
• Trial ID: NCT04135664 on ClinicalTrials.gov

What this trial studies

This phase III trial aims to compare the effectiveness of esophagectomy versus chemoradiation in patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma following endoscopic submucosal dissection. It is a multi-center, randomized trial that includes two treatment arms: one receiving esophagectomy and the other receiving chemoradiation. Additionally, there is a registry arm for patients and surgeons who prefer not to be randomized. The primary goal is to assess the 5-year overall survival rate between the two treatment options, while secondary outcomes include quality of life and relapse-free survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with biopsy-proven esophageal squamous cell carcinoma at clinical N0 and pathological T1b stages.

Not a fit: Patients with prior treatments for esophageal cancer or other primary tumors, distant metastasis, or those unable to understand informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a less invasive treatment option with improved quality of life for patients with early-stage esophageal cancer.

How similar studies have performed: Previous studies have indicated promising outcomes for chemoradiation in similar patient populations, but this specific comparison in a phase III setting is novel.

Eligibility criteria

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.

Where this trial is running

Nanchang, Jiangxi and 5 other locations

• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (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)

Study contacts

• Principal investigator: Zhigang Li, MD, PhD — Shanghai Chest Hospital of Shanghai Jiao Tong University
• Study coordinator: Zhigang Li, MD

Conditions Esophageal Cancer; esophagectomy; chemoradiation; esophageal cancer; endoscopic submucosal dissection