Clinical trial NCT00086996 (phase 2, status: completed)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: fluorouracil, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary adenocarcinoma of the thoracic esophagus or
             gastroesophageal junction

               -  No recurrent disease

               -  Primary esophageal tumor at least 20 cm below the incisors (if < 26 cm below the
                  incisors, a bronchoscopy must be performed and cytology must be negative)

               -  Esophageal disease confined to esophagus and peri-esophageal soft tissue

               -  Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia

          -  Clinical stage II or III disease by CT scan or MRI

               -  If no esophageal mass is detected by these methods, esophageal endoscopic
                  ultrasound is required to determine stage

               -  Positron-emission tomography scan is required to confirm stage

          -  Measurable or non-measurable disease by x-ray, scanning, or physical examination

          -  No celiac axis nodes ≥ 1.5 cm

               -  Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic
                  lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed

               -  Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer
                  by biopsy

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  White blood cell (WBC) count ≥ 3,000/mm^3

          -  Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

        Hepatic

          -  Albumin ≥ 3 g/dL

          -  Bilirubin normal

        Renal

          -  Creatinine ≤ 1.5 times upper limit of normal

        Cardiovascular

          -  No myocardial infarction or cerebrovascular event within the past 6 months

        Pulmonary

          -  No active pneumonia or inflammatory lung infiltrate

        Other

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

          -  No peripheral neuropathy ≥ grade 2

          -  Not pregnant or nursing

          -  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 for esophageal cancer

          -  No concurrent intensity-modulated radiotherapy

        Surgery

          -  No prior surgical resection or attempted surgical resection of esophageal cancer