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

NCT ID: NCT00002883

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-10-31
• Study Completion Date: 2010-08-31

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 combining chemotherapy with surgery is more effective than surgery alone.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

Detailed Description

OBJECTIVES:

• 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.
• Assess whether neoadjuvant fluorouracil/cisplatin increases tumor resectability.

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.

PROJECTED ACCRUAL: A total of 250 patients will be entered.

Conditions

Esophageal Cancer; Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

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

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Ychou, MD, PhD

Role: STUDY_CHAIR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Countries

France

References

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.

Reference Type: RESULT

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.

Reference Type: RESULT

Other Identifiers

FRE-FNCLCC-94012

Identifier Type: -

Identifier Source: secondary_id

EU-96018

Identifier Type: -

Identifier Source: secondary_id

CDR0000065190

Identifier Type: -

Identifier Source: org_study_id