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

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

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.

Inclusion criteria

To be eligible for this study, patient must fulfill all of the following criteria:

1. Histologically confirmed esophageal squamous cell carcinoma

2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification

3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.

4. Aged 18-75 years

5. Adequate organ functions

   1. White blood cell (WBC) ≥3×109⁄L
   2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L
   3. Hemoglobin (Hb) ≥10g⁄dl
   4. Platelet (Plt) ≥100×109⁄L
   5. Total bilirubin <1.5 upper limit of normal (ULN)
   6. Aspartate transaminase (AST) ≤2.5 ULN
   7. Alanine aminotransferase (ALT) ≤2.5 ULN
   8. Creatinine ≤1.5 ULN

6. ECOG PS of 0-2

7. Life expectancy ≥3 months

8. Written informed consent

Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.

1. Esophageal perforation or hematemesis
2. 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)
3. Received thoracic, abdominal or craniocerebral surgery within 30 days
4. Enrolled in other clinical trials within 30 days
5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
6. Severe psychiatric disease
7. Pregnancy, lactation or unwillingness to adopt contraception
8. Drug addiction
9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1
11. History of radiotherapy in the planning area
12. Other ineligible conditions according to researchers