A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma

Study Overview
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Brief Summary
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The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.

Detailed Description
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Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a （according to AJCC2002） Scheme: Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio. Arm Cisplatin: Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles. Arm Paclitaxel: Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.

Official Title
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A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel plus 5-fluorouracil
* Drug: Cisplatin plus 5-fluorouracil
* Radiation: Radiation therapy
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Joined the study voluntarily and signed informed consent form; Age 18-75 Both genders Esophageal squamous cell carcinoma confirmed by pathology Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002) No radiotherapy, chemotherapy or other treatments prior to enrollment PS ECOG 0-2 Life expectancy of more than 3 months Hemoglobin（Hb）≥9 g/dL WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L platelet count (Pt) ≥100x 109/L Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN Renal function: creatinine < 1.5 x ULN No immuno-deficiency Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: Complete esophageal obstruction Deep esophageal ulcer Esophageal perforation Haematemesis After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years Participation in other interventional clinical trials within 30 days Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives Drug addiction Alcoholism or AIDS Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior Patient who has metastasis such as lung, liver metastasis

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: Cisplatin<br>Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles. | Drug: Cisplatin plus 5-fluorouracil<br>* cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).<br>Radiation: Radiation therapy<br>* A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.<br>|
| Experimental: Paclitaxel<br>Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles. | Drug: Paclitaxel plus 5-fluorouracil<br>* 5-ﬂuorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-ﬂuorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).<br>Radiation: Radiation therapy<br>* A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression-free survival |  | 3 years | 
| Local progression-free survival |  | 3 years | 
| Number and grade of Participants with Adverse Events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal squamous cell carcinoma, chemoradiotherapy