Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial
- 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.
- 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
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
PROJECTED ACCRUAL: Approximately 22-66 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of successful study therapy completion and survival after surgery
Thomas Ruhstaller, MD
Kantonsspital St. Gallen