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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer

Treatments: Drug: paclitaxel; Radiation: radiation therapy; Procedure: surgical procedure; Drug: cisplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003087

CDR0000065787 (Registry Identifier)

NCI-T97-0066

97-088

Details and patient eligibility

About

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.

Full description

OBJECTIVES: I. Determine the response rate to preoperative induction paclitaxel/cisplatin followed by concurrent paclitaxel/cisplatin and radiotherapy in locally advanced esophageal cancer. II. Determine the toxic effects, including surgical morbidity and mortality, and patient survival after this combination therapy. III. Monitor the quality of life of patients receiving this combination therapy. IV. Determine c Jun oncogene and thymidylate synthase expression and p53 mutation before and after this combination therapy.

OUTLINE: This is an open label, multicenter study. (Adenocarcinoma stratum closed) Patients receive of induction chemotherapy consisting of paclitaxel IV over 3 hours followed by cisplatin IV on days 1 and 22. Patients then receive radiation therapy 5 days a week for 6 weeks, along with paclitaxel and cisplatin 4 days a week. Patients undergo surgery (complete or partial resection) within 4-8 weeks of completion of the chemoradiotherapy. Patients are followed every 3 months for the first 2 years, every 6 months for the next 2 years, and annually thereafter. Quality of life is assessed for the first year of follow up only.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for each histology (adenocarcinoma, squamous carcinoma) within 18-24 months. (Adenocarcinoma stratum closed)

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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