Combination Chemotherapy in Treating Patients With Esophageal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating esophageal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who are undergoing surgery for esophageal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Treatments: Epirubicin; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the esophagus or type 1 or 2 tumors of the gastroesophageal junction

• Stage IIB or greater by spiral or multi-slice CT scan and endoscopic ultrasound

• Amenable to primary surgery with curative intent

• No para-aortic/celiac lymphadenopathy greater than 1 cm on CT scan and/or greater than 6 mm on endoscopic ultrasound

• No disease invading the airways, aorta, pericardium, or lung

• No liver, lung, or other distant metastases

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm3

• Platelet count greater than 100,000/mm3

Hepatic:

• Liver function tests no greater than 1.5 times normal

Renal:

• Glomerular filtration rate greater than 60 mL/min

Cardiovascular:

• Ejection fraction greater than 50% OR

• Normal echocardiograph

Pulmonary:

• FEV1 greater than 1.5 L

Other:

• Not pregnant or nursing

• No prior primary malignancy

• No significant medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics