Clinical trial: Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Gastroesophageal Adenocarcinoma (NCT01932580)

Eligibility criteria:
Inclusion Criteria:

          -  Histological diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction
             (GEJ), or lower third of the esophagus.

          -  The tumor must be deemed by the team to be potentially resectable. This includes
             imaging studies (detailed below) to clinically stage the tumor and rule out the
             presence of metastatic disease, and includes a preoperative laparoscopic evaluation.

          -  Stage IB (T1N1 only), II, IIIA, IIIB, and IV (T4N1 only)

          -  Life expectancy greater than 3 months

          -  ECOG performance status of 0-2 (i.e. restricted in physically strenuous activity but
             ambulatory and able to carry out work of a light or sedentary nature, e.g., light
             house work, office work).

          -  Adequate hematologic reserve: Platelet count greater than or equal to 100,000
             microlitre, WBC greater than or equal to 2000 microlitre,

          -  Creatinine clearance greater than or equal to 30 ml/min, AST & ALT less than or equal
             to 2 ULN, Alkaline phosphatase less than or equal to 2.5 ULN, bilirubin less than or
             equal ULN

        Exclusion Criteria:

          -  Prior systemic therapy for gastric cancer

          -  Prior docetaxel-containing chemotherapy

          -  Pre-existing medical conditions precluding treatment, including any contraindication
             for major surgery

          -  Pregnancy or lactating mothers. Women of childbearing age must use contraception
             during and for 3 months following treatment

          -  Inability to give informed consent

          -  Inability to maintain nutrition by oral consumption of food alone must have additional
             enteral feeding.

          -  Macroscopic disease noted at laparoscopy

          -  ECOG peformance status of 3 or higher

          -  Unwillingness to undergo investigations and/or treatment as outlined on the study
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