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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.
ClinicalTrials.gov Identifier:
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)

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 Intervention Phase
Esophageal Cancer Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 240
Study Start Date: July 1992
Study Completion Date: June 2001
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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Information from the National Library of Medicine

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
Sponsors and Collaborators
European Institute of Oncology
Study Chair: Ermanno Ancona, MD Azienda Ospedaliera di Padova
  More Information

Ancona E, Ruol A, Santi S, et al.: Major response to neoadjuvant chemotherapy leads to improved long-term survival in potentially resectable (T2-3, any N, M0) esophageal squamous cell carcinoma. Final report of a randomized trial of neoadjuvant chemotherapy versus surgery alone. [Abstract] Proceedings of the European Surgical Association 7th annual meeting, Amsterdam, April 14-15, 2000.

ClinicalTrials.gov Identifier: NCT00002897     History of Changes
Other Study ID Numbers: CDR0000065226
First Submitted: November 1, 1999
First Posted: September 3, 2004
Last Update Posted: September 20, 2013
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
stage II esophageal cancer
stage III esophageal cancer
squamous cell carcinoma of the esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs