Clinical trial: Docetaxel and Capecitabine in Advanced Gastric Cancer (NCT00142038)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with histologically proven adenocarcinoma of the stomach or the GE-junction.

          -  Patients with distant metastases or patients with locally advanced disease who are not
             curatively operable proven by laparoscopy or patients with a recurrence after
             gastrectomy.

          -  Patients who did not receive any prior palliative chemotherapy. An adjuvant
             chemotherapy is allowed.

          -  Age between 18 and 75 years.

          -  Sufficient bone marrow function defined as leucocytes > 3.0 Gpt/l, thrombocytes > 100
             Gpt/l

          -  Sufficient liver function defined as bilirubin < 1.5 mg/dl (1.5 x ULN), ALT and AST <
             3 x ULN.

          -  Sufficient renal function defined as serum creatinine < 1.25 x ULN, or creatinine
             clearance > 60 ml/min calculated according to Cockroft-Gault

          -  Contraception in patients with reproductive potential.

          -  Karnofsky-performance-index at least 60%

          -  Measurable tumor lesions.

          -  Written informed consent of the patient.

        Exclusion Criteria:

          -  Karnofsky-performance-index less or equal 50%.

          -  Patients who already received a palliative first-line chemotherapy.

          -  Prior second malignancy, except basal cell carcinoma of the skin or curatively treated
             carcinoma in situ of the cervix.

          -  Parallel radiation therapy

          -  Uncontrolled infection.

          -  CNS-metastasis

          -  Other severe medical disease

          -  Prior major surgery for less than 2 weeks

          -  Parallel treatment with other experimental therapies.

          -  Parallel treatment with any other therapy aiming against the tumor.

          -  Chronic diarrhea, subileus.

          -  Chronic inflammatory bowel disease or intestinal obstruction.

          -  Unable to take oral medication.

          -  Pregnancy or breast feeding.
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.
Subject must be at most 75 Years

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