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

NCT ID: NCT00016380

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2009-02-10

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

dexamethasone

Intervention Type: DRUG

ondansetron

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Wong, MD

Role: STUDY_CHAIR

Princess Margaret Hospital, Canada

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, Canada

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, Canada

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Northwestern Ontario Regional Cancer Care

Thunder Bay, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 16849762 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

Other Identifiers

CAN-NCIC-SC19

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000068627

Identifier Type: OTHER

Identifier Source: secondary_id

SC19

Identifier Type: -

Identifier Source: org_study_id