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A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis

Phase 3
16 Years
Not Enrolling

Thank you

Trial Information

A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis


- Compare the effectiveness of ondansetron with or without dexamethasone as prophylaxis
for radiation-induced emesis and nausea in patients receiving upper abdominal

- 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

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

Inclusion Criteria


- 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



- 16 and over

Performance status:

- ECOG 0-3

Life expectancy:

- Not specified


- Not specified


- No jaundice

- No moderate to severe hepatic dysfunction


- Not specified


- No active peptic ulcer

- No lactose intolerance


- 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


Biologic therapy:

- Not specified


- At least 1 week since prior cytotoxic therapy

- No concurrent cytotoxic therapy

Endocrine therapy:

- No concurrent corticosteroids other than topical or inhaled preparations


- See Disease Characteristics

- At least 1 week since prior radiotherapy

- No concurrent cranial radiotherapy


- Not specified


- At least 2 days since prior medication with antiemetic intent

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Rebecca Wong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

February 2009

Related Keywords:

  • Cancer
  • nausea and vomiting
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage I gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • recurrent colon cancer
  • recurrent cervical cancer
  • stage IB cervical cancer
  • stage IIB cervical cancer
  • stage IVB cervical cancer
  • stage IA cervical cancer
  • stage IIA cervical cancer
  • stage IVA cervical cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • localized gastrointestinal carcinoid tumor
  • regional gastrointestinal carcinoid tumor
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • localized resectable adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • small intestine adenocarcinoma
  • small intestine lymphoma
  • small intestine leiomyosarcoma
  • localized gallbladder cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • localized extrahepatic bile duct cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent small intestine cancer
  • testicular seminoma
  • carcinoma of the appendix
  • quality of life
  • stage IV pancreatic cancer