Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and
      cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and
      cisplatin together with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together
      with radiation therapy works in treating patients with locally advanced esophageal cancer
      that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the local tumor-control rate in patients with locally advanced, unresectable
           esophageal cancer treated with docetaxel, cisplatin, and radiotherapy.

      Secondary

        -  Determine the feasibility of this regimen in these patients.

        -  Determine the adverse reactions of this regimen in these patients.

        -  Determine local- and distant-failure and time to local- and distant-failure in patients
           treated with this regimen.

        -  Determine overall survival of patients treated with this regimen.

        -  Determine the long-term survival rate in patients treated with this regimen.

        -  Determine whether early improvement of dysphagia is a predictive marker in patients
           treated with this regimen.

        -  Determine quality of life and clinical benefit in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22,
      43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo
      radiotherapy once daily, 5 days a week, for 7 weeks.

      Quality of life is assessed at baseline, at day 22 and 43 during treatment, and then every 3
      months for 1 year after completion of study treatment.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
    

Intervention name(s): Docetaxel and Cisplatin; Radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.; Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage III esophageal cancer; stage IV esophageal cancer