Clinical trial: Gastric Cancer RAD001 Study (NCT01514110)

Eligibility criteria:
Inclusion Criteria:

          -  Histologically or cytologically proven adenocarcinoma of the stomach. Patients who
             have adenocarcinoma of the gastroesophageal junction will be eligible if the majority
             of the tumor bulk is below the junction.

          -  Metastatic or Loco-regionally advanced disease

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral CT /MRI scan. See
             section 11.2 for the evaluation of measurable disease.

          -  Age >= 18 years.

          -  Life expectancy of greater than 12 weeks.

          -  ECOG performance status <= 2 (Karnofsky >= 60%).

        Exclusion Criteria:

          -  Patients who have received more than one line of palliative chemotherapy are allowed,
             provided that (i) the prior chemotherapy does not contain taxane, cisplatin or
             carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study
             treatment, and that (iii) they have recovered from adverse events due to previous
             treatment [except alopecia].

          -  Patients who have had radiotherapy or major surgery within 4 weeks prior to entering
             the study or those who have not recovered from adverse events due to treatment
             administered more than 4 weeks earlier.

          -  Patients who are on CYP3A4 modifiers are excluded from the study

          -  Patients with known brain metastases.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to RAD001.

        Significant cardiovascular disease including unstable angina pectoris, uncontrolled
        hypertension, congestive heart failure related to primary cardiac disease, a condition
        requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a
        myocardial infarction within 6 months prior to the trial entry.

          -  Patients with severe concurrent medical illness such as severe impairment of lung
             function should be excluded from studies of RAD001.

          -  Uncontrolled intercurrent such as, but not limited to, ongoing or active infection, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

          -  Poorly controlled diabetes mellitus

          -  High LDL cholesterol or triglyceride level

          -  Pre-existing neuropathy of >= grade 2

          -  Patients with a history of second malignancies are eligible they have been disease
             free for at least 5 years and are deemed by the investigator to be at low risk of
             recurrence. Par8entswith the following cancers are eligible if diagnosed and treated
             within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell
             or squamous cell carcinoma of the skin

          -  Pregnancy or lactation.
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