Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Study Overview
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Brief Summary
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To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.

Official Title
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Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial

Conditions
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Cervical Esophageal Cancer

Intervention / Treatment
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* Procedure: Esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0); Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included; Aged 18-75 years; Without any contraindication of operation; Hemoglobin >=90 g/L; Leukocytes >=4.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L; Platelet >=100x10^9/L;Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault);INR <=1.5 ULN; APTT <=1.5 ULN; Without other malignancies; Expected R0 resection; ECOG PS 0-1; Volunteered to participate in the study, signed the informed consent form. Exclusion Criteria: Without other malignancies; With mental diseases; With hemorrhagic disease; Inoperable patients; Pregnant or lactating women; Has a history of allergy to paclitaxel or cisplatin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy | Procedure: Esophagectomy<br>* Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference<br>* Other names: Definitive chemoradiotherapy;|
| Active Comparator: Definitive chemoradiotherapy<br>Patients receive definitive chemoradiotherapy | Procedure: Esophagectomy<br>* Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference<br>* Other names: Definitive chemoradiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 5 year overall survival | 5 years after surgery or definitive Chemoradiotherapy is completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngo-esophageal dysfunction free survival | 5 year laryngo-esophageal dysfunction free survival | 5 years after surgery or definitive Chemoradiotherapy is completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal neoplasm, Chemoradiotherapy, Esophagectomy, Overall survival