Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: filgrastim; pegfilgrastim; cisplatin; fluorouracil; paclitaxel; conventional surgery; radiation therapy
Intervention description: During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients >70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42.; During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34.; During induction therapy, patients receive 15 mg/m^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m^2/day by IV over 1 hour beginning on days 57-61.; During induction therapy, patients receive 650 mg/m^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles.; During induction therapy, patients receive 200 mg/m^2/day by IV over 2 hours on days 1 and 29.; Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.; External beam radiotherapy with megavoltage linear accelerators (> 6 MV) will be used to deliver multiple (> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy.
Intervention MeSH terms: Paclitaxel; Fluorouracil; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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 chemotherapy with radiation
      therapy may kill more tumor cells

      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by
      chemoradiotherapy, with or without surgery, works in treating patients with resectable
      locally advanced cancer of the esophagus or gastroesophageal junction.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or
             gastroesophageal junction

               -  Primary (non-recurrent) disease

               -  Amenable to resection

               -  Stage greater than T1, N0 by endoscopic ultrasound

               -  Must be entirely confined to the esophagus or gastroesophageal junction and
                  periesophageal soft tissue

               -  Tumor may not extend more than 2 cm into the stomach

          -  No multiple primary carcinomas of the esophagus

          -  No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus

          -  No evidence of disseminated cancer

               -  Suggestion of liver metastases by positron emission tomography must be proven
                  negative by biopsy or other imaging studies

               -  Palpable supraclavicular nodes must be negative for cancer by biopsy

          -  Bronchoscopy required for lesions less than 26 cm from the incisors to exclude
             tracheoesophageal fistula or invasion

          -  No celiac adenopathy greater than 2 cm

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least 150,000/mm^3

          -  Hemoglobin at least 10 g/dL

        Hepatic

          -  Not specified

        Renal

          -  Creatinine no greater than 1.5 mg/dL AND/OR

          -  Creatinine clearance at least 65 mL/min

          -  Calcium no greater than 11 mg/dL

        Cardiovascular

          -  No uncontrolled heart disease

          -  No uncontrolled hypertension

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to comprehend study requirements and considered likely to comply with study
             parameters

          -  No other malignancy within the past 5 years except curable nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No uncontrolled diabetes

          -  No hypersensitivity to E. coli-derived products

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  More than 5 years since prior systemic chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior chest or upper abdomen radiotherapy

        Surgery

          -  No prior esophageal or gastric surgery

        Other

          -  No concurrent photodynamic therapy

          -  No other concurrent investigational agents for esophageal carcinoma