Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
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|ClinicalTrials.gov Identifier: NCT00002897|
Recruitment Status : Completed
First Posted : September 3, 2004
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Official Title:||RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER|
|Study Start Date :||July 1992|
|Study Completion Date :||June 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002897
|University of Padua|
|Padua, Italy, 35128|
|Study Chair:||Ermanno Ancona, MD||Azienda Ospedaliera di Padova|