Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen

Phase 3

Completed

• Conditions: Cancer

• Registration Number: NCT00016380
• Lead Sponsor: NCIC Clinical Trials Group

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.

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.

Study Timeline

• Study Start: 2001-02-28
• Study First Submitted: 2001-05-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-04-30
• Study Completion: 2009-02-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec; 🇨🇦 Quebec City, Quebec, Canada

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

Fraser Valley Cancer Centre at British Columbia Cancer Agency; 🇨🇦 Surrey, British Columbia, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

British Columbia Cancer Agency - Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

Northwestern Ontario Regional Cancer Care; 🇨🇦 Thunder Bay, Ontario, Canada

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Cancer Care Ontario-London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

CHUS-Hopital Fleurimont; 🇨🇦 Fleurimont, Quebec, Canada

McGill University; 🇨🇦 Montreal, Quebec, Canada