A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.

Official Title
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A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial

Conditions
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Stage III Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel and Cisplatin
* Drug: Paclitaxel and Fluorouracil
* Drug: Paclitaxel and Carboplatin
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria To be eligible for this study, patient must fulfill all of the following criteria: Histologically confirmed esophageal squamous cell carcinoma Clinical stages II, III or IVa based on the 6th UICC-TNM classification No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD. Aged 18-75 years Adequate organ functions White blood cell (WBC) ≥3×109⁄L Absolute neutrophil counts (ANC) ≥1.5×109⁄L Hemoglobin (Hb) ≥10g⁄dl Platelet (Plt) ≥100×109⁄L Total bilirubin <1.5 upper limit of normal (ULN) Aspartate transaminase (AST) ≤2.5 ULN Alanine aminotransferase (ALT) ≤2.5 ULN Creatinine ≤1.5 ULN ECOG PS of 0-2 Life expectancy ≥3 months Written informed consent Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study. Esophageal perforation or hematemesis Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months) Received thoracic, abdominal or craniocerebral surgery within 30 days Enrolled in other clinical trials within 30 days Unstable angina and/or congestive heart failure requiring hospitalization within 6 months Severe psychiatric disease Pregnancy, lactation or unwillingness to adopt contraception Drug addiction Acquired immune deficiency syndrome (AIDS) based upon current CDC definition Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1 History of radiotherapy in the planning area Other ineligible conditions according to researchers

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: Paclitaxel and Cisplatin (TP)<br>Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w*4 | Drug: Paclitaxel and Cisplatin<br>* patients get Paclitaxel and Cisplatin according to protocol<br>* Other names: TP;Radiation: Radiotherapy<br>* 1.8Gy/d, d1-5/week, 34Fx<br>|
| Active Comparator: Paclitaxel and Fluorouracil (TF)<br>Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w*2 | Drug: Paclitaxel and Fluorouracil<br>* patients get Paclitaxel and Fluorouracil according to protocol<br>* Other names: TF;Radiation: Radiotherapy<br>* 1.8Gy/d, d1-5/week, 34Fx<br>|
| Active Comparator: Paclitaxel and Carboplatin（TC）<br>Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w*2 | Drug: Paclitaxel and Carboplatin<br>* patients get Paclitaxel and Carboplatin according to protocol<br>* Other names: TC;Radiation: Radiotherapy<br>* 1.8Gy/d, d1-5/week, 34Fx<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 1year, 2 years, 3 years | 
| adverse event |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal squamous cell carcinoma, concurrent chemoradiotherapy, paclitaxel, cisplatin, carboplatin, fluorouracil