RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER
18 Years
75 Years
Both
Esophageal Cancer
Trial Information
RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is
stage T2-3 Nx M0
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5
years except: Basal cell skin carcinoma Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Ermanno Ancona, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Azienda Ospedaliera di Padova
Authority:
United States: Federal Government
Study ID:
CDR0000065226
NCT ID:
NCT00002897
Start Date:
July 1992
Completion Date:
Related Keywords:
- Esophageal Cancer
- stage II esophageal cancer
- stage III esophageal cancer
- squamous cell carcinoma of the esophagus
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|
