NCT00002897

Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 75 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. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.

Detailed description

OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone. OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and regional lymphadenectomy alone. All patients are followed for survival. PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	fluorouracil
PROCEDURE	conventional surgery

Timeline

• Start date: 1992-07-01
• Completion: 2001-06-01
• First posted: 2004-09-03
• Last updated: 2013-09-20

Locations

1 site across 1 country: Italy