Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	16 and over	Other	CAN-NCIC-SC19 NCT00016380, SC19

Objectives

1. Compare the effectiveness of ondansetron with or without dexamethasone as prophylaxis for radiation-induced emesis and nausea in patients receiving upper abdominal radiotherapy.
2. Compare toxicity of these regimens in these patients.
3. Compare quality of life of patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

A total of 100-200 patients (50-100 per arm) will be accrued for this study.

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.

Wong RK, Paul N, Ding K, et al.: 5-hydroxytryptamine-3 receptor antagonist with or without short-course dexamethasone in the prophylaxis of radiation induced emesis: a placebo-controlled randomized trial of the National Cancer Institute of Canada Clinical Trials Group (SC19). J Clin Oncol 24 (21): 3458-64, 2006.[PUBMED Abstract]

Paul N, Wong R, Brundage Michael, et al.: Symptom assessment in SC19: ondansetron plus dexamethasone as prophylaxis against radiation-induced emesis - a National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study. [Abstract] Support Care Cancer 13 (6): A-04-033, 419, 2005.

Paul N, Wong R, Whitehead M, et al.: Daily diary reporting of symptoms in SC19: a National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study of prophylaxis against radiation-induced emesis. [Abstract] Support Care Cancer 13 (6): A-04-034, 419, 2005.

Wong R, Paul N, Ding K, et al.: Optimizing prophylaxis of radiation induced emesis (RIE): a phase III double blind randomized study comparing ondansetron plus dexamethasone (OndDex) vs ondansetron alone (OndPlac). [Abstract] Support Care Cancer 13 (6): A-04-043, 423, 2005.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Rebecca Wong, MD, Protocol chair		Ph: 416-946-2126 Email: rebecca.wong@rmp.uhn.on.ca

Registry Information
Official Title		A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
Trial Start Date		2001-02-28
Registered in ClinicalTrials.gov		NCT00016380
Date Submitted to PDQ		2001-03-28
Information Last Verified		2003-07-16

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