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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00002897

First received: November 1, 1999

Last updated: February 6, 2009

Last verified: May 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

July 1992

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00002897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Esophageal Cancer

Intervention ^ICMJE

Drug: cisplatin
Drug: fluorouracil
Procedure: conventional surgery

Study Arm (s)

Not Provided

Publications *

Ancona E, Ruol A, Santi S, Merigliano S, Sileni VC, Koussis H, Zaninotto G, Bonavina L, Peracchia A. Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone. Cancer. 2001 Jun 1;91(11):2165-74.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

240

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00002897

Other Study ID Numbers ^ICMJE

CDR0000065226, CNR-012809, EU-96038

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

European Institute of Oncology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Ermanno Ancona, MD

Azienda Ospedaliera di Padova

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2007

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

To Top