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

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00016380

Collaborator

(none)

211

Enrollment

Locations

95.4

Actual Duration (Months)

15.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: dexamethasone Drug: ondansetron Procedure: quality-of-life assessment	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 28, 2001

Actual Primary Completion Date :

Apr 30, 2004

Actual Study Completion Date :

Feb 10, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
2	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
3	Fraser Valley Cancer Centre at British Columbia Cancer Agency	Surrey	British Columbia	Canada	V3V 1Z2
4	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
5	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
6	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
7	Northwestern Ontario Regional Cancer Care	Thunder Bay	Ontario	Canada	P7B 6V4
8	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
9	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
10	CHUS-Hopital Fleurimont	Fleurimont	Quebec	Canada	J1H 5N4
11	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 2M4
12	McGill University	Montreal	Quebec	Canada	H2W 1S6
13	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H4L 2M1
14	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec	Canada	G1R 2J6