Clinical trial: Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach (NCT00601705)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have a histologic diagnosis of adenocarcinoma of the esophagus,
             gastroesophageal junction or gastric cardia, based on biopsy material or adequate
             cytologic exam.

          -  Patients must be clinically staged according to the AJCC 2002 staging system and must
             have either T3-4, or N1 or M1a disease. Staging should include at least an upper
             endoscopy with endoscopic ultrasound and an FDG-PET/CT scan.

          -  Patients must have an ECOG performance status of 0-1.

          -  Patients must have adequate bone marrow function as evidenced by: Absolute neutrophil
             count > 1,500/uL Platelet count > 100,000/uL

          -  Patients must have adequate renal function as evidenced by serum creatinine < 1.6
             mg/dL

          -  Patients must have adequate hepatic function as evidenced by:Serum total bilirubin <
             1.5 mg/dL Alkaline phosphatase < 3X the institutional ULN AST/ALT < 3X the
             institutional ULN

          -  Patients must have adequate pulmonary function as evidenced by an FEV1 > 50%
             predicted.

          -  Patients or their legal representatives must be able to read, understand, provide and
             sign informed consent to participate in the trial.

          -  Patients of childbearing potential agree to use an effective form of contraception
             during the study and for 90 days following the last dose of study medication (an
             effective form of contraception is an oral contraceptive or a double barrier method)

          -  Age > 18 years

        Exclusion Criteria:

          -  Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma,
             small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma etc,) will be ineligible.

          -  Patients with any evidence of distant hematogenous or distant nodal disease (M1b) will
             be ineligible.

          -  No prior chemotherapy, radiation therapy or surgery for this malignancy will be
             allowed. Prior endoscopic debulking, laser therapy or dilatation will not exclude a
             patient.

          -  Patients with another active malignancy will not be eligible except for curatively
             treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or
             localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive
             evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of
             entry

          -  Patients with an active infection will not be eligible.

          -  Patients with known hypersensitivity to any of the components of oxaliplatin,
             epirubicin, fluorouracil or cisplatin will not be eligible.

          -  Patients who are receiving any other concurrent investigational therapy, or who have
             received investigational therapy within 30 days of the first scheduled day of protocol
             treatment (investigational therapy is defined as treatment for which there is
             currently no regulatory authority approved indication) will not be eligible.

          -  Patients with a baseline peripheral neuropathy greater than or equal Grade 2 will not
             be eligible.

          -  Patients who are pregnant or lactating will not be eligible.

          -  Patients with any other medical condition, including mental illness or substance
             abuse, deemed by the Investigator to be likely to interfere with a patient's ability
             to sign informed consent, cooperate and participate in the study, or interfere with
             the interpretation of the results, will not be eligible.

          -  Patients with any history of an allogeneic transplant will not be eligible.

          -  Patients with known infection with HIV, Hepatitis B or C (active, previously treated
             or both) will not be eligible.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment