A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
16 Years
N/A
Both
Cancer
Trial Information
A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Cancer patients who are scheduled to receive radiotherapy within the next 3 weeks
- Total dose at least 2,000 cGy delivered in at least 15 fractions
- 1 fraction per day, 5 days per week
- Treatment field to include an area of at least 80 cm2 in the anterior/posterior
direction encompassing the upper abdomen
- At risk of developing radiation-induced emesis
- No emesis (retching and/or vomiting) or nausea with severity greater than 2 within
the past week
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-3
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No jaundice
- No moderate to severe hepatic dysfunction
Renal:
- Not specified
Gastrointestinal:
- No active peptic ulcer
- No lactose intolerance
Other:
- No concurrent condition or illness that contraindicates corticosteroids, serotonin
antagonists, or prochlorperazine (e.g., diabetes mellitus)
- No prior unusual or allergic reaction to a serotonin antagonist (ondansetron,
dolasetron, or granisetron), corticosteroid, or prochlorperazine
- No condition that would preclude accessibility to treatment or follow-up
- Able and willing to complete diary and quality of life questionnaires in either
English or French
- Able to swallow
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 1 week since prior cytotoxic therapy
- No concurrent cytotoxic therapy
Endocrine therapy:
- No concurrent corticosteroids other than topical or inhaled preparations
Radiotherapy:
- See Disease Characteristics
- At least 1 week since prior radiotherapy
- No concurrent cranial radiotherapy
Surgery:
- Not specified
Other:
- At least 2 days since prior medication with antiemetic intent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Principal Investigator
Rebecca Wong, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
United States: Federal Government
Study ID:
SC19
NCT ID:
NCT00016380
Start Date:
February 2001
Completion Date:
February 2009
Related Keywords:
- Cancer
- 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
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