NCT00021320

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	fluorouracil
DRUG	paclitaxel
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 2000-05-01
• Primary completion: 2004-01-01
• Completion: 2009-04-01
• First posted: 2003-01-27
• Last updated: 2014-05-09

Locations

1 site across 1 country: United States