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

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.

Sex

All

Minimum age

16 Years

Maximum age

120 Years

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

• RESULTNational Cancer Institute of Canada Clinical Trials Group (SC19); Wong RK, Paul N, Ding K, Whitehead M, Brundage M, Fyles A, Wilke D, Nabid A, Fortin A, Wilson D, McKenzie M, Ackerman I, Souhami L, Chabot P, Pater J. 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. 2006 Jul 20;24(21):3458-64. doi: 10.1200/JCO.2005.04.4685. PMID 16849762
• RESULTPaul 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.
• RESULTPaul 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.
• RESULTWong 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.