Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or large cell undifferentiated cancer of the esophagus or gastroesophageal junction T3, N1, or M1a disease only The following types are not allowed: Small cell undifferentiated carcinomas, lymphomas, or sarcomas Small cell or mixed small cell/non-small cell histology No evidence of distant hematogenous tumor metastases (M1b) No malignant pleural effusions PATIENT CHARACTERISTICS: Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC > 3,500/mm^3 Platelet count > 100,000/mm^3 Hepatic Alkaline phosphatase < 2 times normal AST < 2 times normal No unstable or uncompensated hepatic disease Renal Creatinine ≤ 2.0 mg/dL Calcium normal No unstable or uncompensated renal disease Cardiovascular No unstable or uncontrolled angina No unstable or uncompensated cardiac disease Pulmonary See Disease Characteristics No limitations to pulmonary function that would preclude study participation No evidence of clinically active interstitial lung disease (asymptomatic patients with chronic stable radiographic changes are allowed) No unstable or uncompensated respiratory disease Other Not pregnant or nursing Fertile patients must use effective contraception No evidence of severe or uncontrolled systemic disease No other uncontrolled malignancy No active infection No known severe hypersensitivity to gefitinib or any of its excipients PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for this cancer Chemotherapy No prior chemotherapy for this cancer Radiotherapy No prior radiotherapy for this cancer Surgery Recovered from any prior oncologic or other major surgery No prior surgical resection for this cancer No concurrent ophthalmic surgery Other No prior photodynamic therapy for this cancer (prior laser treatments are acceptable) More than 30 days since prior unapproved or investigational drug No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center