Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
 Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that
 it can be removed during surgery.

 PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
 therapy given before surgery in treating patients who have stage I, stage II, or stage III
 esophageal cancer.
OBJECTIVES: I. Determine the total response rate in patients with stage I, II, or III
 esophageal cancer treated with paclitaxel, carboplatin, and fluorouracil with concurrent
 radiotherapy followed by surgical resection. II. Determine the overall survival of these
 patients treated with this regimen. II. Determine the toxicity of this regimen in this
 patient population.

 OUTLINE: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30
 minutes on days 1 and 22, and fluorouracil IV continuously on days 1-42. Patients undergo
 radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks. Patients then
 undergo surgical resection within 3-5 weeks following completion of therapy. Patients are
 followed every 3 months for 6 months, every 6 months for 1 year, and then annually
 thereafter.

 PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma
 of the upper, middle, or lower third esophagus Stage I, II, or III disease Measurable
 disease No distant metastases Negative liver biopsy Negative bone scan unless due to benign
 disease No tracheobronchial involvement No vocal cord paralysis No phrenic nerve
 involvement No celiac axis lymph node involvement unless due to primary cancer at
 gastroesophageal junction No evidence of disseminated cancer

 PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
 Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
 least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL
 SGOT/SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no
 greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance
 at least 60 mL/min Cardiovascular: No uncontrolled or severe cardiovascular disease No
 congestive heart failure No myocardial infarction within the past 6 months No severe or
 uncontrolled hypertension (systolic greater than 150 mmHg and diastolic greater than 100
 mmHg) Pulmonary: FEV1/FVC at least 75% predicted Arterial blood saturation at least 92%
 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
 contraception No other malignancy except curatively treated nonmelanoma skin cancer or
 carcinoma in situ of the cervix No other serious medical illness that would limit survival
 to fewer than 2 years No active uncontrolled bacterial, viral, or fungal infection No
 active uncontrolled duodenal ulcer No psychiatric disorder that would preclude study

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
 chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest radiotherapy
 Surgery: No prior surgical resection of tumor Other: No prior therapy for esophageal cancer