Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

Not Applicable

Recruiting

• Conditions: Esophagus Cancer
• Interventions: Procedure: CRT; Procedure: surgery

• Registration Number: NCT02972372
• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

Brief Summary

The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.

Detailed Description

Background: More than half of global esophageal cancer cases came from China, but the report about definitive chemoradiation (CRT) compared with esophagectomy in Chinese patients with locally advanced resectable esophageal squamous cell cancer (ESCC) is limited.

Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT).

Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients.

Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-06
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Chinese
• esophageal squamous cell cancer
• mid or lower esophageal cancer
• tumor is resectable disease
• clinical stage: cT1bN+Mo, or cT2-4aN0-2M0

Exclusion Criteria

• who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
• who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT group	CRT	3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in IMRT mode (total of 50Gy given in 25 fractions) will be given over a period 5-6 weeks.
Surgery group	surgery	The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy

Primary Outcome Measures

Name	Time	Method
2-year disease-free survival rate	2 year	The percent of 2 year disease-free survival after random allocation, percent

Secondary Outcome Measures

Name	Time	Method
Treatment-related adverse events	2 year	The percent of treatment-related adverse events after 2 year random allocation, percent
QoF (quality of life)	2 year	The quality of life evaluation after 2 year of random allocation by questionnaire, 1-10 score, 1 means poor and 10 means best
2 year overall survival	2 year	The percent of 2 year overall survival after random allocation, percent

Trial Locations

Locations (2)

Anyang Tumor Hospital; 🇨🇳 Anyang, Henan, China

The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China