Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

OBJECTIVES:

- Determine the pathologic complete response rate in patients with locally advanced
cancer of the esophagus or gastroesophageal junction treated with radiotherapy
administered concurrently with paclitaxel, carboplatin, and fluorouracil before
esophagectomy.

- Determine the tolerability of this regimen in these patients.

- Determine the tumor response rate in patients treated with this regimen.

- Determine the quality of life of patients treated with this regimen.

- Assess the relationship between the presence of genetic polymorphisms in these patients
and the toxicity of this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and
fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients
undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the
absence of disease progression or unacceptable toxicity. Patients with stable or responding
disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete
dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery,
patients who underwent curative resection may receive a maximum of 2 additional courses of
paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2
weeks before surgery.

Patients are followed every 3 months for 4 years.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma
of the thoracic esophagus (below 20 cm) or gastroesophageal junction

- Surgically resectable disease (T1-3; NX, N0, or N1; M1a)

- T4 tumors that are not unequivocally unresectable allowed

- Celiac lymph node (stations 15-20) involvement allowed

- Must be considered a potential surgical candidate by a thoracic or general surgeon

- No supraclavicular lymph node involvement by palpation, biopsy, or radiograph
(greater than 1.5 cm)

- No distant metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

- Patients with ECOG 2 must be considered good candidates for study by treating
oncologists

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 3 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- No New York Heart Association class III or IV heart disease

Other

- No uncontrolled infection

- No other severe underlying disease that would preclude study participation

- No grade 2 or greater peripheral neuropathy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for esophageal cancer

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to anticipated fields of study radiotherapy

Surgery

- Not specified

Other

- No concurrent diuretics

- No concurrent amifostine