Clinical trial: Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer (NCT00414271)

Eligibility criteria:
Inclusion Criteria:

          -  Age greater than or equal 18 years.

          -  Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia
             (Siewert Classification Type III)

          -  Preoperative Stage T3-4NxM0 by endoscopic ultrasound, CT of the abdomen/pelvis and
             laparoscopy. (CT of the chest if it is a cardia lesion).

          -  Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination.

          -  Patients must not have received any prior chemotherapy or hormonal therapy for the
             treatment of gastric cancer.

          -  Karnofsky performance status of 70 or higher.

          -  Estimated life expectancy of at least 12 weeks.

          -  Adequate organ function including the following:

          -  Bone marrow:

               -  White blood cells (WBC) greater than or equal 3.5 x 109/L

               -  Absolute neutrophil (segmented and bands) count (ANC) greater than or equal 1.5 x
                  109/L

               -  Platelets greater than or equal 100 x 109/L

               -  Haemoglobin greater than or equal 9g/dL

          -  Hepatic:

               -  Bilirubin within upper limit of normal (ULN),

               -  ALT or AST less than or equal 2.5x ULN

               -  Alkaline phosphatase less than or equal 2.5x ULN.

          -  Renal:

               -  creatinine less than or equal 1.5x ULN

          -  Signed informed consent by patient or legal representative.

          -  Patients with reproductive potential must use an approved contraceptive method if
             appropriate (eg, intrauterine device, birth control pills, or barrier device) during
             and for three months after the study. Females with childbearing potential must have a
             negative serum pregnancy test within 7 days prior to study enrollment.

        Exclusion Criteria:

          -  Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic
             disease will render patient ineligible according to American Joint Committee on Cancer
             (AJCC) staging manual. (See appendix 11.4).

          -  Treatment within the last 30 days with any investigational drug.

          -  Concurrent administration of any other cancer therapy, including cytotoxic
             chemotherapy, hormonal therapy, and immunotherapy.

          -  Active infection that in the opinion of the investigator would compromise the
             patient's ability to tolerate therapy.

          -  Pregnancy.

          -  Breast-feeding.

          -  Serious concomitant disorders that would compromise the safety of the patient or
             compromise the patient's ability to complete the study, at the discretion of the
             investigator.

          -  Poorly controlled diabetes mellitus with fasting blood sugar > 18 mmol/L(mM).

          -  Second primary malignancy that is clinically detectable at the time of consideration
             for study enrollment.

          -  History of significant neurological or mental disorder, including seizures or
             dementia.

          -  History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for
             commercial docetaxel formulations.

          -  History of hypersensitivity to 5-fluorouracil
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