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: Randomizedphase III trial to compare the effectiveness of ondansetron with or without dexamethasone in preventing vomiting in patients with cancer who are receiving radiation therapy to the upper abdomen.

Condition	Treatment or Intervention	Phase
Endocrine Cancer female reproductive cancer Gastrointestinal Cancer nausea and vomiting Quality of Life	Drug: dexamethasone  Drug: ondansetron  Procedure: nausea and vomiting therapy  Procedure: quality-of-life assessment  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  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

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, British Columbia
      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
Canada, Nova Scotia
      Nova Scotia Cancer Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      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
Canada, Quebec
      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

Study chairs or principal investigators

Rebecca Wong, MD,  Study Chair,  Princess Margaret Hospital   

Study ID Numbers:  CDR0000068627; CAN-NCIC-SC19
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00016380
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08