Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Condition: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Cancer; Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms; Esophageal Neoplasms
Intervention: capecitabine; docetaxel; fluorouracil; oxaliplatin; radiation therapy; therapeutic conventional surgery
Intervention description: Given PO; Given IV; Given IV; Given IV; Undergo radiation therapy; Undergo surgery
Intervention MeSH terms: Docetaxel; Capecitabine; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; adenocarcinoma of the gastroesophageal junction; stage IIIA gastric cancer; stage IIIB gastric cancer; stage IIIC gastric cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer

Summary:

      This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine,
      fluorouracil, and radiation therapy works compared with fluorouracil when given together with
      oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or
      gastroesophageal junction that has spread from where it started to nearby tissue or lymph
      nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and
      fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination
      chemotherapy) together with radiation therapy before surgery may make the tumor smaller and
      reduce the amount of normal tissue that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histological confirmation of adenocarcinoma of the esophagus, gastroesophageal (GE)
             junction, or gastric cardia

          -  Tumor must be considered surgically resectable; Note: patients with T4N0M0 tumors that
             are potentially resectable are also eligible

          -  Nodal involvement: patients with involvement of celiac nodes, (stations 15-20) are
             eligible if the primary lesion is mid-thoracic, distal esophagus or GE junction;
             patients with supraclavicular node involvement are eligible with upper thoracic
             esophagus primary lesions

          -  Capable of swallowing pills

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

          -  Absolute neutrophil count (ANC) >= 1500

          -  Peripheral platelet count >= 100,000

          -  Hemoglobin >= 9.0 g/dL

          -  Total bilirubin =< 1.5 x upper normal limit (UNL)

          -  Serum glutamic oxaloacetic transaminase (SGOT) (alanine aminotransferase [AST]) =< 3 x
             UNL

          -  Creatinine =< 1.5 x UNL

          -  Negative pregnancy test done =< 7 days prior to registration, for women of
             childbearing potential only

          -  Provide informed written consent

          -  Willingness to return to NCCTG enrolling institution for follow-up

          -  Patient willing to provide mandatory tissue and blood samples for research purposes

          -  Patient willing to allow use of FDG PET/CT scans for mandatory research purposes

        Exclusion Criteria

          -  Evidence of distant metastases

          -  Palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or
             radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for
             lesions in mid-thoracic, distal thoracic or GE junction

          -  T1N0M0 or T2N0M0 tumor stage

          -  Any of the following

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception

          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
             of the investigator, would make the patient inappropriate for entry into this study or
             interfere significantly with the proper assessment of safety and toxicity of the
             prescribed regimens

          -  Immunocompromised patients (other than that related to the use of corticosteroids)
             including patients known to be human immunodeficiency virus (HIV) positive

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Uncontrolled diabetes (i.e., will interfere with the performance of the FDG PET/CT
             scans)

          -  Receiving current treatment or prior treatment for this malignancy

          -  Other active malignancy 5 years prior to registration, except non-melanotic skin
             cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy,
             patient must not be receiving other specific treatment (other than hormonal therapy)
             for cancer

          -  Prior radiation to > 30% of the marrow cavity