Clinical trial: FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in Patients With Esophageal Adenocarcinoma (NCT02037048)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have a histologic diagnosis of adenocarcinoma of the esophagus, GEJ, or
             GC based on biopsy material or adequate cytologic exam; tumors of the GC are defined
             as originating within 5 cm of the GEJ

          -  Patients must be clinically staged according to the 7th edition (2010) of the American
             Joint Committee on Cancer (AJCC) staging system and must have either clinical T3-4a,
             or ≥ N1 disease; staging should include upper endoscopy with endoscopic ultrasound and
             a fludeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT)
             scan (with diagnostic CT abdomen/pelvis preferred)

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0-1

          -  Absolute neutrophil count ≥ 1,500/ul

          -  Platelet count ≥100,000/ul

          -  Serum creatinine (Scr) ≤ 1.5mg/dl; if the Scr > 1.5, patients may still be eligible if
             the calculated glomerular filtration rate (GFR) (Cockroft-Gault) is ≥ 40ml/minute

          -  Serum total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3X the institutional ULN

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3X the institutional
             ULN

          -  Patients with Gilbert's syndrome are eligible provided the total bilirubin is ≤ 3 and
             the remainder of the liver function tests (ALT, AST, alkaline phosphatase [ALK Phos])
             are within the institutional normal range

          -  Patients must have a forced expiratory volume in one second (FEV-1) and diffusing
             capacity of the lung for carbon monoxide (DLCO) > 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 must agree to use an effective form of
             contraception during this study and for 90 days following the last dose of
             chemotherapy; an effective form of contraception is an oral contraceptive or a double
             barrier method

        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 evidence of clinical T4b (unresectable) or M1 (distant metastasis)
             according to the AJCC 2010 staging system will be ineligible

          -  No prior chemotherapy, radiation therapy, or surgery for this malignancy will be
             allowed; prior endoscopic procedures for superficial disease (endoscopic mucosal
             resection, cryotherapy, photodynamic therapy, etc.) will not exclude a patient; prior
             dilatation is also allowed

          -  Patients with another active malignancy will not be eligible except for:

               -  Resected basal cell carcinoma and squamous cell carcinoma of the skin, cervical
                  or prostatic intraepithelial neoplasia, and ductal or lobular carcinoma in situ
                  of the breast

               -  Patients with localized prostate cancer who have received curative intent therapy
                  are also eligible provided:

                    -  Surgically treated patients have an undetectable prostate specific antigen
                       (PSA)

                    -  Patients treated with brachytherapy have a PSA within the institutional
                       normal range

                    -  Patients who have received pelvic external beam radiotherapy are not
                       eligible

          -  Patients with a clinically apparent active infection will not be eligible (please
             note, an isolated elevation in the white blood cell count, by itself, does not
             constitute evidence of an infection)

          -  Patients with known hypersensitivity to any component of the chemotherapy regimen will
             not be eligible

          -  Patients with a baseline peripheral neuropathy ≥ grade 2 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 as defined as treatment for which there is
             currently no regulatory authority approved indication) will not be eligible

          -  Patients who are pregnant or lactating will not be eligible; pregnant patients are
             ineligible

          -  Patients with angina, a cardiac ejection fraction < 50%, or ischemic heart disease are
             not eligible

          -  Patients with any other medical condition, including mental illness or substance
             abuse, deemed by the investigator to be likely to interfere with the 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 solid organ or bone marrow transplant will not be
             eligible

          -  Patients with a known history of infection with hepatitis B or hepatitis C virus
             (active, previously treated, or both) will not be eligible due to the increased risk
             of hepatotoxicity and viral reactivation associated with systemic chemotherapy

          -  Patients with known infection with human immunodeficiency virus (HIV) 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? Contradiction