Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to
      stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
      high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation
      therapy before surgery may shrink the tumor so that it can be removed.

      PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together
      with chemoradiotherapy followed by surgery works in treating patients with locally advanced,
      resectable esophageal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy
           followed by surgery, in terms of pathological response rate, in patients with locally
           advanced, resectable esophageal cancer.

        -  Determine the feasibility of this regimen, in terms of successful completion of therapy
           and survival at 30 days postoperatively, in these patients.

      Secondary

        -  Determine the parameters of disease control in these patients and toxicity of this
           regimen and compare these parameters with published results.

        -  Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with
           predictive value with regard to tumor response and long-term disease control in patients
           treated with this regimen.

        -  Determine the quality of life of patients treated with this regimen.

        -  Determine the clinical benefit of this regimen in these patients.

      OUTLINE: This is a multicenter study.

        -  Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV
           over 1 hour on days 1 and 22.

        -  Chemoradiotherapy: Beginning 21 days after the last dose of neoadjuvant chemotherapy,
           patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week
           and undergo radiotherapy 5 days a week for 5 weeks.

        -  Surgery: Patients undergo surgery 3-8 weeks after the final administration of
           radiotherapy.

      Treatment continues in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy,
      before surgery, and then every 3 months for 1 year.

      Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: Approximately 22-66 patients will be accrued for this study.
    

Intervention name(s): Cisplatin and Docetaxel
Intervention type(s): Drug
Intervention description(s): cisplatin and docetaxel chemo- and radiochemotherapy
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus