Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)
Condition: Stomach Cancer; Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Intervention: 5-Fluorouracil; Folinic Acid; Oxaliplatin; Radiotherapy; Surgery
Intervention description: 2.2 Gm/m^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43.
Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump.; 200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.; 100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43.
Chemoradiotherapy: 45 mg/m^2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week).; 45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.; 4-6 weeks after completion of chemoradiotherapy, restaged & surgical resection of the primary tumor and lymph nodes attempted.
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Oxaliplatin; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Stomach Cancer; Gastric Cancer; Adenocarcinoma of the Stomach; Gastroesophageal Junction; Esophageal; Gastric; 5-Fluorouracil; 5-FU; Adrucil; Efudex; Folinic Acid; Oxaliplatin; Eloxatin; Chemoradiotherapy; Radiation; Radiotherapy; XRT

Summary:

      The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid
      and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or
      gastroesophageal cancers that will be removed by surgery if possible. The safety of this
      combination therapy will also be studied.
    

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.