Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus

Study Overview
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Brief Summary
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The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.

Detailed Description
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Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.

Official Title
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A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Other: Paclitaxel plus Cisplatin with radiotherapy
* Other: S1 plus Cisplatin with radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven squamous cell carcinoma of esophagus . Locally advanced esophageal cancer , with no operation indication M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer Subjects haven't been given neither radiotherapy nor chemotherapy before Age of 18-70 PS ≦2 Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl With no difficulty in eating Expected lifetime ≧3 months Exclusion Criteria: Invasion to surrounding organ ( T4 disease ) . Distant metastasis , except M1a disease . Complete obstruction of the esophagus, or patients who have the potential to develop perforation Women in status of pregnancy Patients who have complications exist as following: Uncontrolled angina and heart failure, have a history of hospitalization in 3 months A history of myocardial infarction in the past 6 months There is a need for antibiotic treatment of acute bacterial or fungal infection Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization Drug addiction, alcoholism and AIDS disease or long-term virus carriers Uncontrollable seizures, or loss of insight because of mental illness

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel plus Cisplatin with radiotherapy<br>patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin | Other: Paclitaxel plus Cisplatin with radiotherapy<br>* we want to compare which regime is better with radiotherapy, PT regime (paclitaxel and cisplatine ) Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation. Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.<br>|
| Experimental: S1 plus Cisplatin with radiotherapy<br>patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin | Other: S1 plus Cisplatin with radiotherapy<br>* we want to compare which regime is better with radiotherapy,SP regime (Tegafur Gimeracil Oteracil Potassium Capsule and cisplatine). Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation. Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | five years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | five years after enrollment |