RecruitingPhase 3NCT04135664

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

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


Sponsor

Shanghai Chest Hospital

Enrollment

176 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments — surgery (esophagectomy, removal of part of the esophagus) versus chemoradiation (chemotherapy combined with radiation) — for patients with early-stage esophageal cancer that has been confirmed by a minimally invasive procedure called endoscopic submucosal dissection. **You may be eligible if...** - You have biopsy-proven squamous cell cancer of the esophagus located in the chest - Imaging shows no spread to lymph nodes - The cancer is confirmed as stage T1b (invaded the inner wall but not the muscle) after endoscopic removal - You are between 18 and 75 years old - Your general health is good (ECOG performance status 0-1) **You may NOT be eligible if...** - You have already had prior treatment for this cancer before the endoscopic procedure - Your cancer has spread to distant parts of the body - Your tumor is larger than 5 cm in length on endoscopy - The tumor takes up more than three-quarters of the inner lining of the esophagus - You cannot give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREesophagectomy

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

COMBINATION_PRODUCTchemoradiation

concurrent chemotherapy and radiotherapy

OTHERactive surveillance

No further adjuvant therapy


Locations(6)

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, China

View Full Details on ClinicalTrials.gov

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NCT04135664


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