Status:
RECRUITING
Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 endosc...
Detailed 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 li...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04135664
Start Date
September 1 2019
End Date
December 1 2027
Last Update
October 22 2019
Active Locations (6)
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1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, JX 791
2
Changhai Hospital, The Second Military Medical University
Shanghai, China, SH 21
3
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, China, SH 21
4
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China, SH 21