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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

Page last updated: June 20, 2008

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