S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: fluorouracil; oxaliplatin; conventional surgery; radiation therapy
Intervention description: Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.; Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.; The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.; Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.
Intervention MeSH terms: Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in
      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. Oxaliplatin and fluorouracil may make
      tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving
      chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be
      removed.

      PURPOSE: This phase II trial is studying how well giving oxaliplatin together with
      fluorouracil and radiation therapy works in treating patients who are undergoing surgery for
      stage II or stage III cancer of the esophagus or gastroesophageal junction.
    

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