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

• Status: Completed
• Trial end date: 2009-02-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ondansetron

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