Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016380
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2001-05-06
Brief Title:
Ondansetron WithOut Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-SC19 | OTHER | None | None |
| CDR0000068627 | OTHER | PDQ | None |