Clinical trial: Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach (NCT01472029)

Eligibility criteria:
Inclusion Criteria:

        - Histologically confirmed adenocarcinoma of the gastroesophageal junction (AEG I-III) or
        the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following
        specifications: Endosonography and an esophageal-gastro-duodenoscopy; Categorization of
        gastroesophageal junction tumors according to the classification by Siewert (1987, cf.
        appendix 2)

          -  Detection of an adenocarcinoma with HER2 3+ (IHC) or HER2 2+ (IHC) with amplification
             proven by FISH, SISH or CISH by an accredited local pathologist (for quality assurance
             tumor samples have to be available for a subsequent central review)

          -  No preceding cytotoxic or targeted therapy

          -  Male and female patients aged ≥ 18 years. If able to reproduce, patients must be
             willing to use highly effective methods of contraception during treatment and for 6
             months after the end of treatment (adequate: methods fulfilling the requirements of
             the Note for guidance on non-clinical safety studies for the conduct of human clinical
             trials for pharmaceuticals [CPMP/ICH/286/95 mod]). Female patients with reproductive
             ability must have performed a negative pregnancy test within 7 days of study entry.

          -  ECOG ≤ 2

          -  Exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI (if
             osseous lesions are suspected due to clinical signs)

          -  Laparoscopic exclusion of peritoneal carcinomatosis, if suspected clinically

          -  Adequate haematological, hepatic and renal function parameters: Leukocytes ≥ 3000/mm³,
             platelets ≥ 100,000/mm3; Serum creatinine ≤ 1.5 x upper limit of normal, or GFR > 40
             ml/min; Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.5 x upper limit of
             normal, alkaline phosphatase ≤ 6 x upper limit of normal

          -  Normal cardiac ejection fraction, as assessed by echocardiography

          -  Written patient consent form

        Exclusion Criteria:

          -  Known hypersensitivity against trastuzumab, murine proteins, 5-FU, leucovorin,
             oxaliplatin or docetaxel

          -  Other known contraindications against trastuzumab, 5-FU, leucovorin, oxaliplatin, or
             docetaxel

          -  Clinically significant active coronary heart disease, cardiomyopathy or congestive
             heart failure, NYHA III-IV

          -  Clinically significant valvular defect

          -  Past or current history of other malignancies not curatively treated and without
             evidence of disease for more than 5 years, except for curatively treated basal cell
             carcinoma of the skin and in situ carcinoma of the cervix

          -  Known brain metastases

          -  Severe dyspnoea at rest due to complications of advanced malignancy or requiring
             supplementary oxygen therapy

          -  Other severe internal disease or acute infection

          -  Peripheral polyneuropathy > NCI Grade II

          -  Chronic inflammatory bowel disease

          -  On-treatment participation in another clinical study in the period 30 days prior to
             inclusion and during the study

          -  Subject pregnant or breast feeding, or planning to become pregnant within 6 months
             after the end of treatment

          -  Patients in a closed institution according to an authority or court decision (AMG §
             40, Abs. 1 No. 4)

          -  Any other concurrent antineoplastic treatment including irradiation
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? 1