Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
Condition: Esophageal Cancer; Gastroesophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: 5-Fluorouracil; Oxaliplatin; Radiation Therapy; Surgery
Intervention description: Arm A = 250 mg/m^2 IV over 24 hours for 5 days weekly for 5 weeks.
Arm B = 2.2 mg/m^2 IV over 48 hours on days 1 and 15.; Arm A: 40 mg/m^2 IV daily over 2 hours for 5 weeks
Arm B: 100 mg/m^2 IV on Day 1 and 15; Radiation treatment every weekday for 5 weeks.; Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.
Intervention MeSH terms: Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No
Keywords: Esophageal Cancer; Gastroesophageal Cancer; Gastroesophageal Junction; Radiation Therapy; 5-Fluorouracil; 5-FU; Adrucil; Efudex; Oxaliplatin

Summary:

      The goal of this clinical research study is to learn if a combination of the investigational
      drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is
      as effective as a combination of these two drugs given before and during radiation therapy in
      the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of
      therapy will also be compared.

      Objectives:

      Primary objective:

      Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in
      the resected surgical specimen between Arms A and B.

      Secondary objectives:

        1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates,
           safety, and local plus systemic relapse rates between Arms A and B

        2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to
           assess predictive markers of response and outcome.

        3. Evaluate the joint effects, including possible interactive effects, of
           proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates,
           safety, and local plus systemic relapse rates.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or
             gastroesophageal junction.

          2. Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.

          3. Normal liver (serum glutamic-pyruvic transaminase (SGPT) < 56µL, Total Bilirubin <1.5
             mg/dL), kidney (Creatinine <1.75 mg/dL), and bone marrow functions (AGN >1,500µL,
             platelet count >100,000/µL).

          4. Performance status 0 or 1.

          5. Signed informed consent by the investigator or their designee and patient.

          6. Medically fit for surgery.

          7. No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal
             enlargement unless biopsy negative.

          8. None of the celiac nodes should be larger than 2 cm

          9. Male or Female but both sexes must practice adequate contraception while on therapy

         10. >/=18 years but less than 76 years

         11. No known allergy to any of the study drugs.

         12. No prior therapy for this cancer.

         13. No significant cancer (defined as non-melanomatous skin cancers and treated cervical
             cancers) within the past 5 years

         14. New York Heart Association (NYHA) I and II

        Exclusion Criteria:

          1. Patients with T1N0, T4, or M1b cancer will be excluded

          2. Significant comorbid conditions (defined as uncontrolled diabetes, active angina or
             heart failure, uncontrolled hypertension, or active psychiatric condition that
             prevents consistent participation and compliance).

          3. More than grade 1 neuropathy

          4. Unable to comprehend the requirements of the study or comply with it.