Clinical trial: Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma (NCT00183911)

Eligibility criteria:
Inclusion Criteria:

          -  Histologic dx of locally advanced gastric adenocarcinoma (requires upper endoscopy
             with bx of lesion and CT scan of chest, abdomen, and pelvis with iv and oral contrast
             or other methods of imaging to confirm absence of metastatic dz) (Untreated patients
             with histologically documented gastric/GEJ ca stages IB-IV [M0] are eligible)

          -  Based on post-op pathological findings, diagnosis and staging has to confirm stage
             IB-IV (M0) adenocarcinoma of stomach or GEJ.

          -  Patients who underwent emergency surgery for indications such as GI obstruction,
             perforation, or hemorrhage, or patients with surgery already performed, are eligible
             provided surgery is considered curative

          -  ECOG performance status 0-2

          -  AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb
             greater than or equal to 9.0· Total bilirubin less than or eqal to 2.0; SGOT/SGPT less
             than or equal to 2.5 x uln; alk phos less than or equal to 2.5 x uln

          -  BUN less than or equal to 30; creatinine less than or equal to 1.5 or CrCl >60 ml/min

          -  Negative b-HCG pregnancy test (females with reproductive potential)

          -  PT, aPTT, and thrombin time within range of normal

          -  Evidence of at least unilateral renal function as established by CT scan with contrast
             or nephrogram. (If only one kidney is present, at least 2/3 of the functioning kidney
             must be excluded from any RT port)

        Exclusion Criteria:

          -  Prior radiation therapy, chemotherapy or immunotherapy

          -  Presence of another active invasive malignancy (Except for adequately treated basal
             cell or squamous cell skin ca, in-situ cervical ca, or other cancer for which patient
             has been disease-free for at least 5 yrs)

          -  Active or uncontrolled infection, including HIV

          -  Psychiatric disorders that would interfere with informed consent· Pregnant or nursing
             women (Patients of reproductive age must agree to use effective contraceptive method)

          -  Any other severe concurrent disease, which in the judgment of MD would make patient
             inappropriate for study
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