Different Radiation Dose With Concurrent Chemotherapy for Thoracic Esophageal Carcinoma
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      Definitive chemoradiation is the standard treatment for locally advanced esophageal cancer.
      NCCN (National Comprehensive Cancer Network) recommends radiation dose of 50-50.4 Gy as the
      definitive radiation dose for esophageal cancer with definitive chemo-radiation. However, as
      many studies in China showed that the most common recurrence site after definitive
      chemo-radiation was within the radiation region. But there have not been large randomized
      clinical trials to investigate the optimal radiation dose with concurrent chemotherapy for
      esophageal cancer in China. The purpose of this clinical trial is to investigate the optimal
      radiation dose for thoracic esophageal squamous cell cancer with definitive concurrent
      chemoradiotherapy.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine if high-dose radiation with concurrent chemotherapy increases overall
      survival for thoracic esophageal squamous cell carcinoma

      SECONDARY OBJECTIVES:

      I. To evaluate if high-dose radiation with concurrent chemotherapy increased progression-free
      survival for thoracic esophageal squamous cell carcinoma II.To evaluate if high-dose
      radiation with concurrent chemotherapy increased local control for thoracic esophageal
      squamous cell carcinoma

      OUTLINE:

      Patients are randomized to one of the two treatment arms

      ARM 1:Patients receive high-dose radiation with concurrent chemotherapy.High-dose RT:59.4 Gy
      in 33 fractions, 1.8 Gy per fraction, 5days/week.concurrent chemotherapy: Paclitaxel 50mg/m2
      D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After that, patients receive
      consolidative platinum-based 3-week chemotherapy for 2 cycles.

      ARM 2:Patients receive standard-dose radiation with concurrent chemotherapy.Standard-dose
      RT:59.4 Gy in 33 fractions, 1.8 Gy per fraction, 5days/week . Concurrent chemotherapy:
      Paclitaxel 50 mg/m2 D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After
      that, patients receive consolidative platinum-based 3-week chemotherapy for 2 cycles.

      After completion of study therapy, patients are followed up every 3-4 months for 2 years,
      then every 6 months for 3 years.
    

Intervention name(s): High-dose; Standard-dose
Intervention type(s): Radiation; Radiation
Intervention description(s): Drug: concurrent chemotherapy with radiation paclitaxel plus carboplatin are used weekly in both arms; Drug: concurrent chemotherapy with radiation paclitaxel plus carboplatin are used weekly in both arms
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: High dose radiation plus chemotherapy of paclitaxel and carboplatin vs standard dose radiation plus chemotherapy of paclitaxel and carboplatin.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Esophageal cancer, radiation, chemotherapy