Esophageal Cancer
Conditions
Keywords
stage 0 esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
Brief summary
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.
Detailed description
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.
Interventions
DRUGcisplatin
DRUGfluorouracil
DRUGpaclitaxel
PROCEDUREconventional surgery
PROCEDUREneoadjuvant therapy
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction * Potentially resectable disease * No malignant celiac node involvement * No cervical esophageal carcinoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,800/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Other: * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No significant medical or psychiatric illness that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for esophageal cancer Endocrine therapy: * Not specified Radiotherapy: * No prior thoracic radiotherapy Surgery: * See Disease Characteristics * No prior surgical resection of esophageal tumor
Countries
United States
Outcome results
None listed