Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen
Condition: Cancer
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Antiemetic drugs may help to reduce or prevent vomiting in patients treated with
      radiation therapy. It is not yet known if ondansetron is more effective with or without
      dexamethasone in preventing vomiting caused by radiation therapy.

      PURPOSE: This randomized phase III trial is comparing how well ondansetron works with or
      without dexamethasone in preventing vomiting in patients with cancer who are receiving
      radiation therapy to the upper abdomen.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effectiveness of ondansetron with or without dexamethasone as prophylaxis
           for radiation-induced emesis and nausea in patients receiving upper abdominal
           radiotherapy.

        -  Compare toxicity of these regimens in these patients.

        -  Compare quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to radiotherapy field description (whole abdomen and pelvis vs
      partial abdomen and pelvis vs partial abdomen only). Patients are randomized to 1 of 2
      treatment arms.

        -  Arm I: Patients receive oral ondansetron twice daily and oral dexamethasone daily for
           5-7 days concurrently with the first 5 fractions of radiotherapy.

        -  Arm II: Patients receive oral ondansetron twice daily and oral placebo daily for 5-7
           days concurrently with the first 5 fractions of radiotherapy.

      Treatment continues in both arms in the absence of disease progression or unacceptable
      toxicity.

      Quality of life is assessed at baseline, prior to starting radiotherapy if more than 5 days
      since randomization, prior to the 5th and 15th fractions of radiotherapy, and 1 month after
      completion of radiotherapy.

      Patients are followed at 1 month.

      PROJECTED ACCRUAL: A total of 100-200 patients (50-100 per arm) will be accrued for this
      study.
    

Intervention name(s): dexamethasone; ondansetron; quality-of-life assessment
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Dexamethasone; Ondansetron
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: nausea and vomiting; stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage I gastric cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer; recurrent colon cancer; recurrent cervical cancer; stage IB cervical cancer; stage IIB cervical cancer; stage IVB cervical cancer; stage IA cervical cancer; stage IIA cervical cancer; stage IVA cervical cancer; stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; localized gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; localized resectable adult primary liver cancer; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; small intestine adenocarcinoma; small intestine lymphoma; small intestine leiomyosarcoma; localized gallbladder cancer; unresectable gallbladder cancer; recurrent gallbladder cancer; localized extrahepatic bile duct cancer; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer; recurrent small intestine cancer; testicular seminoma; carcinoma of the appendix; quality of life; stage IV pancreatic cancer