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

Esophageal Cancer Clinical Trial

Official title:

RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002897
• Other study ID #: CDR0000065226
• Secondary ID: CNR-012809EU-960
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: July 1992
• Est. completion date: June 2001

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Italy	University of Padua	Padua

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 chemothera

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 squamou — View Citation