Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
      chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin
      together with radiation therapy works in treating patients with esophageal or
      gastroesophageal junction cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the pathologic complete response in patients with adenocarcinoma of the
           esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising
           capecitabine, oxaliplatin, and radiotherapy.

      Secondary

        -  Determine the clinical response rate in patients treated with this regimen.

        -  Determine the recurrence rate, time to progression, and patterns of failure in patients
           treated with this regimen.

        -  Characterize the toxicity profile of this regimen in these patients.

      OUTLINE:

        -  Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and
           oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2
           courses in the absence of disease progression or unacceptable toxicity.

        -  Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once
           weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and
           undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease
           progression or unacceptable toxicity.

        -  Surgery: Patients undergo surgical resection at 4-8 weeks after completion of
           chemoradiotherapy.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): Induction Therapy - Capecitabine; Induction Therapy - Oxaliplatin; Combination Therapy - Capecitabine; Combination Therapy - Oxaliplatin; Combination Therapy - Radiation; Evaluation for response and surgery
Intervention type(s): Drug; Drug; Drug; Drug; Radiation; Procedure
Intervention description(s): Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.; Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.; Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.; Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.; 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.; Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.
Intervention MeSH terms: Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the esophagus; stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer