A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

Official Title
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A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

Conditions
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Stage II and III Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: DCX
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable. Patients must not have received any prior anticancer therapy. More than 6 months of expected survival. Age ranges from 18 to 70 years. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney. Karnofsky performance status (KPS) of 90 or more. Signed informed consent document on file. Exclusion Criteria: Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine. Patients with concomitant hemorrhagic disease. Pregnant or breast feeding. Inability to use gastric conduit after esophagectomy because of a prior surgery. Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCX and surgery<br>docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy | Drug: DCX<br>* docetaxel, cisplatin and capecitabine<br>Procedure: surgery<br>* Ivor Lewis Esophagectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic response rate | Pathologic response rate is defined as tumor regression score | 2 years | 
| Disease-free survival |  | 2 years | 
| Incidence of adverse event based on CTCAE 4.0 | Incidence of adverse event in patients during treatment period graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 | 2 years |