Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)
Condition: Stomach Cancer; Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Oxaliplatin and 5-FU are chemotherapy drugs that are commonly used to treat certain kind of
      cancers. Folinic Acid (leucovorin) acts with 5-FU to increase cancer cell death.

      Before treatment begins, you will be asked questions about your medical history and have a
      complete physical exam. You will have around 1 tablespoon of blood drawn for routine tests.
      You will have your height and weight measured. You will have a chest x-ray and an
      electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will
      also have a chest x-ray, barium study of the upper gastrointestinal tract, and a CT scan to
      check the size and location of the tumor. Women who are able to have children must have a
      negative blood pregnancy test.

      All patients will have had a routine upper gastrointestinal tract endoscopy and biopsy with
      endoscopic ultrasound examination prior to participating in this trial. However, once
      participating in this trial, the upper gastrointestinal tract endoscopy will be repeated
      prior to surgery. This procedure involves examination of the esophagus, stomach, and duodenum
      by a flexible tube. Biopsies will be taken as necessary.

      You will receive treatment with 5-FU as an infusion into a vein using a continuous 24- hour
      portable pump. This will start on Day 1 and will continue for 48 hours. You will need to
      carry this pump with you at all times for 48 hours. The pump is about the size of a Sony
      Walkman®. You will also receive Oxaliplatin as an infusion into a vein over 2 hours on Day 1.
      Folinic Acid will be given as an infusion into a vein over 30 minutes on Day 1. You will have
      12 days to recover between chemotherapy treatments. These drugs may be given to you as an
      outpatient. Treatment will be repeated on Day 15. Two 14-day treatment periods are called one
      cycle. You will receive up to 8 weeks of the above chemotherapy (2 cycles).

      If the cancer gets worse or you experience intolerable side effects, you will be taken off
      the study and your doctor will discuss other treatment options with you.

      Each week while you are receiving chemotherapy, around 1 tablespoon of blood will be drawn
      for routine tests.

      Twelve days after you complete the second cycle of chemotherapy, you will begin to receive
      chemoradiotherapy (chemotherapy given at the same time as radiation therapy). Before
      chemoradiotherapy, you will be given a full physical, upper GI x-rays, about a tablespoon of
      blood will be drawn for routine blood tests, and if needed, a CT of the abdomen, chest and
      pelvis will be performed.

      You will receive radiation therapy every weekday for a total of 25 sessions. During radiation
      therapy, 5-FU will be infused into your vein using a continuous infusion portable pump that
      you will carry with you day and night for up to 5 days (from Monday to Friday) of every week
      for 5 weeks. On Day 1 of radiation therapy each week, you will be given an infusion of
      Oxaliplatin into your vein over 2 hours for 5 weeks. During radiation therapy, you will be
      evaluated once a week and about one tablespoon of blood drawn for routine blood tests. Your
      doctor will discuss with you whether you will receive proton or x-ray radiation. If you
      receive proton radiation, it will be given in a building that is about a 5-minute drive from
      the M. D. Anderson radiation clinic.

      If the cancer gets worse or you experience intolerable side effects, your treatment may be
      delayed or you may be taken off study and your doctor will discuss other treatment options
      with you.

      Four to six weeks after the completion of chemoradiotherapy, the stage of the cancer will be
      evaluated. This includes drawing blood (about a tablespoon) for routine tests, chest x-ray,
      CT of the abdomen, chest, and pelvis (when necessary), upper GI endoscopy, and abdominal
      disease staging (if necessary).

      When re-staging is complete, surgical removal of the primary tumor and lymph nodes will be
      attempted. All patients will be eligible for surgery. The J-tube will be left in your body
      for at least 8 weeks after the surgery to supplement your nutrition.

      You will be asked to fill out side effect sheets throughout your participation in this
      research study. You will be asked questions regarding nausea, hair loss, fatigue, meals, and
      other questions regarding your daily activities.

      Following this study, you will be asked to come for follow-up visits at M. D. Anderson at 3,
      6, 9, and 12 months after surgery. You will then come in for visits every 6 months until Year
      3, then once a year until Year 5. At these visits, you will have a full physical, about one
      tablespoon of blood drawn for routine tests, a chest x-ray, upper GI radiographs, upper GI
      endoscopy (every other visit) and CT of the abdomen (as needed).

      This is an investigational study. Oxaliplatin is FDA approved and commercially available for
      the treatment of advanced colorectal cancer. Oxaliplatin is not approved in the US for the
      treatment of gastric cancer. 5-FU and folinic acid are commercially available drugs. The
      combination of these 3 drugs (Oxaliplatin + 5-FU + Folinic Acid) is investigational. A total
      of up to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.
    

Intervention name(s): 5-Fluorouracil; Folinic Acid; Oxaliplatin; Radiotherapy; Surgery
Intervention type(s): Drug; Drug; Drug; Radiation; Procedure
Intervention description(s): 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.
Other intervention name(s): 5-FU; Adrucil; Efudex; Eloxatin; XRT
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Oxaliplatin; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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