Expired Study
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Philadelphia, Pennsylvania 19111


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00021320


Primary Contact:

Study Chair
Jonathan Cheng, MD
Fox Chase Cancer Center


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19111
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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