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

NCT04135664 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2019-10-22

No results posted yet for this 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).

Conditions

  • Esophageal Cancer

Interventions

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

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Zhigang Li, MD, PhD · Shanghai Chest Hospital of Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135664 on ClinicalTrials.gov