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About
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain.
PURPOSE: This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.
Full description
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, histology (epidermoid vs glandular), response to induction therapy (complete vs partial), and tumor differentiation (little differentiated vs undifferentiated/good vs moderately differentiated).
Quality of life is assessed at baseline, after treatment on arms I or II, and then every 2 months (arm I) or every 6 months (arm II) thereafter.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria:
No cervical tumor
No T1, T2, or T4 tumors
No tracheo-esophageal fistula or tracheal invasion
No gastric cardia cancer by gastroscopy
No visceral (e.g., lung, bone, brain, liver), ganglion, or clavicular metastases
PATIENT CHARACTERISTICS:
WHO performance status 0-2
Creatinine normal
WBC ≥ 3,000/mm^3
Neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Transaminases ≥ 60%
Bilirubin ≤ 2.0 mg/dL
No cirrhosis
DLCO ≥ 1.5 L with or without hypoxemia at rest
No progressive coronary insufficiency
Weight loss ≤ 15%
No other malignancy in the past 2 years
Must be able to maintain sufficient enteral nutrition (2,000 calories/day)
No contraindication to radiotherapy
No recurring left paralysis
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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