Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Procedure: CRT
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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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.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRT group<br>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. | Procedure: CRT<br>* Drug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total Other Names: Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. Other Names: Aiheng cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85. 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88. Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity<br>* Other names: concurrent chemoradiotherapy;|
| Active Comparator: Surgery group<br>The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy | Procedure: surgery<br>* The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy<br>* Other names: esophagectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year disease-free survival rate | The percent of 2 year disease-free survival after random allocation, percent | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related adverse events | The percent of treatment-related adverse events after 2 year random allocation, percent | 2 year | 
| QoF (quality of life) | 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 | 
| 2 year overall survival | The percent of 2 year overall survival after random allocation, percent | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, chemoradiation, esophagectomy