Clinical trial: Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients (NCT00526110)

Eligibility criteria:
Inclusion Criteria:

          1. Histologically documented adenocarcinoma of the stomach or Gastroesophageal Junction
             (GEJ).

          2. Age >18 years;

          3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;

          4. Chemotherapy: No prior chemotherapy is permitted for metastatic disease. Use of prior
             chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a
             radiosensitization is permitted, provided that the minimum time from completion of
             such treatment to study entry is at least 12 months;

          5. Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of
             bone marrow reserve provided that they have recovered from the acute, toxic effects of
             radiotherapy prior to registration. A minimum of 14 days must have elapsed since the
             end of radiotherapy.

          6. Previous Surgery: Previous surgery is permitted provided that wound healing has
             occurred prior to registration. Minimum of 14 days must have elapsed between a major
             surgery and start of chemotherapy.

          7. At least one target lesion >20 mm (or >10 mm on spiral CT-scan). If indicator lesions
             are in a previously irradiated field, only a clear disease progression of the
             irradiated lesion or a new lesion in the previously irradiated field will be accepted

          8. Adequate baseline bone marrow, hepatic and renal function, defined as follows:
             Neutrophils >1.5 * 10*9/L and platelets >100 * 10*9/L; Bilirubin <1.5 * upper limit of
             the normal range (ULN); aspartate aminotransferase (AST or SGOT) and/or alanine
             aminotransferase (ALT or SGPT) <2.5 * ULN; Serum creatinine <1.5 * ULN;

          9. Patients must give written informed consent to participate in the study.

         10. Patients - both males and females - with reproductive potential (ie, menopausal for
             less than 1 year and not surgically sterilized) must practice effective contraceptive
             measures throughout the study. Women of child-bearing potential must have a negative
             pregnancy test (serum or urine) within 14 days prior to registration.

        Exclusion Criteria:

          1. Concurrent anticancer therapy

          2. Pregnant or lactating women

          3. History of other prior malignancy except for adequately treated basal cell or squamous
             cell skin cancer; in situ cervical cancer or malignancy from which the patient has
             been disease-free for 5 years;

          4. Brain metastases

          5. Patients with active or uncontrolled infections or with serious illnesses or medical
             conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV
             and/or cirrhosis

          6. History of any psychiatric condition that might impair the patient's ability to
             understand or to comply with the requirements of the study or to provide informed
             consent.

          7. Known hypersensitivity to any of the drugs.
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