Clinical trial NCT00016380: Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: 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
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 211
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Centre for the Southern Interior
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Northwestern Ontario Regional Cancer Care
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Rebecca Wong, MD
role: STUDY_CHAIR
References:
citation: National 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.
citation: Paul 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.
citation: Paul 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.
citation: Wong 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.