Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: dexamethasone (Drug); ondansetron (Drug); quality-of-life assessment (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Cancer Institute of Canada Official(s) and/or principal investigator(s):
Rebecca Wong, MD, Study Chair, Affiliation: Princess Margaret Hospital, Canada
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.
Clinical Details
Official title: A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
Study design: Supportive Care, Randomized, Double-Blind, Placebo Control
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia V1Y 5L3, Canada
British Columbia Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada
Fraser Valley Cancer Centre at British Columbia Cancer Agency, Surrey, British Columbia V3V 1Z2, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia B3H 1V7, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario N6A 4L6, Canada
Northwestern Ontario Regional Cancer Care, Thunder Bay, Ontario P7B 6V4, Canada
Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario M4N 3M5, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec H4L 2M1, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec G1R 2J6, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec J1H 5N4, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec H1T 2M4, Canada
McGill University, Montreal, Quebec H2W 1S6, Canada
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2001
Last updated: May 23, 2008
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