A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma

• Survival rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• Disease free survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
• Survival rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

• toxicities of neo-adjuvant chemoradiotherapy [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
  Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0).
• assessment in perioperation [ Time Frame: perioperative period ] [ Designated as safety issue: Yes ]
  Removal rate， Time of operation， Quantity of bleeding， Thoracic Drainage， Days of Hospitalization， Rate of Operative Complication， Mortality of perioperation，
• efficacy of neo-adjuvant chemoradiotherapy [ Time Frame: 2 weeks after neo-adjuvant chemoradiotherapy ] [ Designated as safety issue: No ]
  Criteria:Response Evaluation Criteria in Solid Tumors，RECIST

The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.

• Procedure: Neo-adjuvant Chemoradiotherapy followed by Surgery

  1. Radiotherapy combined with concomitant chemotherapy:

     Radiotherapy Program:External radiation with a total dose of 40.0Gy is given in 20 fractions of 2.0Gy,5 fractions a week.

     neo-chemotherapy program: Navelbine 25mg/m2, IV (in the vein) on day 1 and day 8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle;or Cisplatin 25mg/m2,IV DRIP on day 1 to day 4 of each 21 day cycle.

     Number of cycles:two

  2. surgery:Mckeown Modification Surgery ang total two-field lymphadenectomy
• Procedure: surgery
  two field lymphadenectomy

• Experimental: experimental group
  Neo-adjuvant Chemoradiotherapy followed by Surgery
  Intervention: Procedure: Neo-adjuvant Chemoradiotherapy followed by Surgery
• Active Comparator: control group
  only Surgery
  Intervention: Procedure: surgery

Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
6. Karnofsky performance status more than 90.
7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
2. Patients with concomitant hemorrhagic disease.
3. Pregnant or breast feeding.
4. Inability to use gastric conduit after esophagectomy because of a prior surgery.
5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

• Cancer Hospital of Shantou University
• Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
• Fudan University
• Zhejang cancer hospital
• Tai Zhou Hospital of Zhejiang Province
• The Second People's Hospital of Sichuan