Clinical trial: Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ) (NCT00525785)

Eligibility criteria:
Inclusion Criteria:

          1. Patients with potentially resectable adenocarcinoma of the stomach with histologic
             proof of adenocarcinoma, clinically staged T2-3, any N, M0 or T1N1M0 Gastric carcinoma
             may involve the gastroesophageal junction, however, the bulk of the tumor must be in
             the stomach (defined by radiographs, endoscopy, or endoscopic ultrasonography).

          2. No prior major surgery of the stomach or radiation therapy to the stomach or
             immunotherapy or chemotherapy.

          3. Patients must have a performance status of < 2 Zubrod scale.

          4. Patients must have adequate bone marrow function (defined as peripheral absolute
             granulocyte count of >1,500/µL, and platelet count of > 100,000/µL), adequate liver
             function (bilirubin <= 1.5 mg/dl), and adequate renal function (creatinine <= 1.5
             mg/dl).

          5. Pretreatment evaluations must be done per the guidelines in Section 8.0.

          6. A feeding jejunostomy must be inserted in all patients.

          7. Patient must sign an informed consent prior to study entry.

          8. Patient must be chronologic <= 75.

        Exclusion Criteria:

          1. Patients with T1N0 MO or T4 carcinoma documented by endoscopic ultrasonography.

          2. Positive cytology of pleural, or pericardial effusion or patients with any peritoneal
             disease diagnosed by laparoscopy.

          3. Biopsy proof of lymph node metastases outside the study field such as supraclavicular,
             mediastinal, or para-aortic nodes.

          4. Evidence of metastatic disease to distant organs (biopsy is suggested for questionable
             findings).

          5. Patients with cardiac disease graded as New York Heart Association Class III or IV,
             severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.

          6. Patients with diabetic neuropathy.

          7. Abnormalities of mental status such that either the patient cannot fully comprehend
             the therapeutic implications of the protocol or comply with the requirements.

          8. Presence of concurrent or previous malignancies in the past 5 years (except for
             resected squamous or basal cell carcinoma of the skin).

          9. Pregnant women are excluded from study entry due to the potential teratogenic effects
             of the study treatment.
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? 1