A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma

Detailed Description
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The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.

Official Title
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A Randomized Controlled Trial of Chemotherapy With 5FU and Cisplatin Before and After Surgery for Stage II,III Squamous Cell Carcinoma of the Thoracic Esophagus:JCOG9907

Conditions
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Esophageal Neoplasms, Carcinoma, Squamous Cell

Intervention / Treatment
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* Drug: Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2
* Drug: (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven squamous cell carcinoma of the thoracic esophagus pathologic stages IIa, IIb, III except T4 an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 no previous history of chemotherapy nor radiotherapy an essentially normal clinical laboratory profile (white blood cell count or WBC, >=4,000 /mm3; hemoglobin or Hb, >=10g/dl; platelet count or Plt, >=100,000 /mm3; total serum bilirubin<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, <=1.2 mg/dl; creatinine clearance or CCr, >=60 ml/minute; and arterial oxygen tension or PaO2, >=65 torr oral or written informed consent obtained before randomization Exclusion Criteria: severe heart diseases uncontrollable hyper tension or diabetes mellitus severe pulmonary dysfunction HBs positive active bacterial infection synchronous or metachronous (within 5 years) malignancy pregnant female psychiatric medication

Ages Eligible for Study
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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

| Intervention/Treatment |
| --- |
|Drug: Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2|nan|
|Drug: (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | year | 
| Toxicity of chemotherapy |  | year | 
| Operative morbidity |  | year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, squamous cell carcinoma, esophagectomy, neoadjuvant chemotherapy, esophageal squamous cell carcinoma