Study of Docetaxel or Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Esophageal Cancer
Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Oesophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T4aN0M0, according to 7th edition of Union for International Cancer Control (UICC) staging system.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival
- Age ranges from 18 to 70 years
- 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.
- WHO performance status (PS) of 0-1
- Signed informed consent document on file
Exclusion Criteria:
- Patients have received any prior anticancer therapy
- Patients with advanced inoperable or metastatic esophageal carcinoma
- Patients with concomitant hemorrhagic disease
- Patients with other uncontrollable status that cannot tolerate surgery
- Pregnant or breast feeding
- Patients cannot signed the informed consent document because of psychological quality, family and social factors
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more
- Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer
- Have a history of diabetes over 10 years and with poorly controlled blood sugar level
- patients with serious cardiac, respiratory, hepatic, renal, hematologic, immunological disease or cachexy, who cannot tolerate chemoradiotherapy or surgery
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
A (DP-RT)
B (NP-RT)
• Arm A consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy and 4 weekly cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: Radiation: (44 Gy/20 fractions) Drug: Docetaxel Drug: Cisplatin
• Arm B consists of the concurrent chemoradiotherapy followed by surgery. The patient will receive 4 weeks of radiation therapy and 2 cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Each cycle of chemotherapy lasts 21 days/3 weeks. The drugs include Vinorelbine and Cisplatin. Interventions: Radiation: (44 Gy/20 fractions) Drug: Vinorelbine Drug: Cisplatin