Esophageal Cancer Clinical Trial
Official title:
Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer
RATIONALE: Drugs used in chemotherapy 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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or
without radiation therapy in treating patients who have esophageal cancer.
OBJECTIVES:
- Determine the median and two-year disease-free and overall survival of patients with
resectable esophageal cancer treated with neoadjuvant paclitaxel, cisplatin, and
fluorouracil with concurrent radiotherapy.
- Determine the complete and partial responses in patients treated with this regimen.
- Assess the toxicity of this regimen in these patients.
- Determine the optimal dose of paclitaxel when administered in this regimen in these
patients.
- Determine the effect of tumor tubulin isoform expression on chemosensitivity and
overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 2 courses.
Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent
chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days
1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5
days a week for 5 weeks.
At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection.
Patients with local progressive disease after 2 courses of initial chemotherapy undergo
surgical resection instead of receiving concurrent chemoradiotherapy.
Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2
years.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
;
Primary Purpose: Treatment
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