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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002897
First Posted: September 3, 2004
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
November 1, 1999
September 3, 2004
September 20, 2013
July 1992
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Complete list of historical versions of study NCT00002897 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Procedure: conventional surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
June 2001
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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

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00002897
CDR0000065226
CNR-012809
EU-96038
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European Institute of Oncology
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Study Chair: Ermanno Ancona, MD Azienda Ospedaliera di Padova
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP