Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients without local failure measured 6 months after completion of study treatment
6 months
No
Razvan Popescu, MD
Study Chair
Hirslanden Klinik Aarau
Switzerland: Swissmedic
SAKK 76/02
NCT00238407
March 2004
August 2010
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