Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Under 76 Other FRE-FNCLCC-94012 EU-96018, NCT00002883

Objectives

1. Compare survival in patients with operable adenocarcinoma of the lower third of the esophagus or the cardia treated with fluorouracil/cisplatin vs. no chemotherapy prior to surgical resection.
2. Assess whether neoadjuvant fluorouracil/cisplatin increases tumor resectability.

Entry Criteria

Disease Characteristics:

• Adenocarcinoma of the lower third of the esophagus or the cardia for which complete resection is feasible
  • Extension to the cardia allowed
  • Cancer of the cardia with extension to the esophagus or stomach allowed
    • No in situ cancer of the cardia
  • No distant metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for tumors of the cardia

Endocrine therapy

• No prior radiotherapy for tumors of the cardia

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• Not over 75

Performance status:

• WHO 0 or 1

Hematopoietic:

• WBC at least 4,000
• Polymorphonuclear lymphocytes greater than 2,000
• Platelets at least 100,000

Hepatic:

• Not specified

Renal:

• Creatinine less than 1.3 mg/dL (120 micromoles/L)

Cardiovascular:

• No prior myocardial infarction
• No other cardiac contraindication to surgery

Pulmonary:

• No respiratory contraindication to surgery

Other:

• No second malignancy except:
• Basal cell carcinoma of the skin
• Adequately treated in situ carcinoma of the uterine cervix

Expected Enrollment

A total of 250 patients will be entered.

Outline

This study is randomized for neoadjuvant chemotherapy. Patients are stratified by performance status, tumor location, and randomizing center.

Patients randomized to no neoadjuvant chemotherapy undergo resection of the tumor with adequate margins and resection of regional lymph nodes (R2 with at least 8 nodal groups recommended).

Patients randomized to neoadjuvant chemotherapy receive fluorouracil and cisplatin at 3-4 week intervals; fluorouracil is given by continuous intravenous infusion for 5 days and cisplatin is given on the first 2 days of fluorouracil administration. Tumor response is assessed after 2 courses; responding patients with no serious toxicity receive a third course. Surgery, as above, is initiated 4-6 weeks after the second or third course of chemotherapy. Upon recovery (within 3-6 weeks), patients who responded to neoadjuvant chemotherapy receive 3-4 additional courses of postoperative chemotherapy (maximum total of 6 courses). Patients whose best response was stable disease are assessed for postoperative radiotherapy.

Patients on either arm with positive resection margins, positive lymph nodes, or equivocal complete resection are referred for postoperative radiotherapy. Further therapy for patients with incomplete resection is at the discretion of the physician.

Patients are followed every 3-4 months for at least 5 years.

Boige V, Pignon J, Saint-Aubert B, et al.: Final results of a randomized trial comparing preoperative 5-fluorouracil (F)/cisplatin (P) to surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC ACCORD07-FFCD 9703 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4510, 200s, 2007.

Ychou M, Pignon JP, Lasser P, et al.: Phase III preliminary results of preoperative fluorouracil (F) and cisplatin (P) versus surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC 94012-FFCD 9703 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-4026, 2006.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Marc Ychou, MD, PhD, Protocol chair		Ph: 33-4-6761-3066 Email: mychou@valdorel.fnclcc.fr

Registry Information
Official Title		A PROSPECTIVE RANDOMISED TRIAL OF INDUCTION CHEMOTHERAPY WITH 5-FU CONTINUOUS IV INFUSION AND CISPLATIN VERSUS SURGERY IN RESECTABLE ADENOCARCINOMA OF THE LOW THIRD OF THE ESOPHAGUS AND CARDIOESOPHAGEAL JUNCTION
Trial Start Date		1996-10-04
Registered in ClinicalTrials.gov		NCT00002883
Date Submitted to PDQ		1996-10-04
Information Last Verified		2001-04-27

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