Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen
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|ClinicalTrials.gov Identifier: NCT00016380|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 3, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: dexamethasone Drug: ondansetron Procedure: quality-of-life assessment||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis|
|Actual Study Start Date :||February 28, 2001|
|Actual Primary Completion Date :||April 30, 2004|
|Actual Study Completion Date :||February 10, 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016380
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Fraser Valley Cancer Centre at British Columbia Cancer Agency|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Northwestern Ontario Regional Cancer Care|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Toronto Sunnybrook Regional Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Fleurimont, Quebec, Canada, J1H 5N4|
|Montreal, Quebec, Canada, H1T 2M4|
|Montreal, Quebec, Canada, H2W 1S6|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H4L 2M1|
|Centre Hospitalier Universitaire de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Study Chair:||Rebecca Wong, MD||Princess Margaret Hospital, Canada|