Combination Chemotherapy, Radiation Therapy and Surgery in Treating Patients With Cancer of the Esophagus

• Status: Completed
• Trial end date: 2005-02-01
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy before surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients with cancer of the esophagus that can be surgically removed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (adenocarcinoma stratum closed) Locally advanced and surgically resectable (T2-4 N0-1 M0) T1 N1 tumors are eligible, T1 N0 tumors and in situ carcinoma are not eligible No cervical esophageal tumors No brain, pulmonary, liver, bone, lymph node (cervical or supraclavicular) or other distant metastases No positive cytology of the pleura, pericardium, or peritoneum No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Calcium no greater than 12 mg/dL Cardiovascular: No New York Heart Association class III/IV heart disease No history of active angina No myocardial infarction within 6 months No history of significant ventricular arrhythmia requiring medication No history of clinically significant conduction system abnormality Pulmonary: FEV1 at least 1.2 L Other: Not pregnant or nursing Negative pregnancy test No serious concurrent infections or uncontrolled nonmalignant medical illnesses No psychosis No clinically significant hearing loss No recurrent laryngeal nerve or phrenic nerve paralysis No concurrent active malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix Prior malignancies without evidence of disease for at least 5 years allowed

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No other concurrent radiotherapy Surgery: Not specified