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AzTrials

CancerPhase 3NCT00016380

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

A Phase 3 study testing dexamethasone, ondansetron and quality-of-life assessment in people with Cancer, run by NCIC Clinical Trials Group at 14 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 120 years
Conditions the study is for
Cancer
What is being tested?
dexamethasone, ondansetron and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
211 participants
Where
14 sitesCanada
Study dates
28 Feb 2001to 10 Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Canada14 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H4L 2M1

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Fraser Valley Cancer Centre at British Columbia Cancer Agency

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Care

    Thunder Bay, Ontario, P7B 6V4

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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.

Read the 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
Being tested
dexamethasone, ondansetron, quality-of-life assessment
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
Medical subject headings
Neoplasms, Nausea, Vomiting, Colonic Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start28 Feb 2001
  3. Primary completion30 Apr 2004
  4. Study completion10 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016380
Sponsor's protocol ID
SC19
Other IDs
CAN-NCIC-SC19, CDR0000068627
Status last verified
Apr 2020
First submitted
6 May 2001
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16849762

  • 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.

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dexamethasone, ondansetron and quality-of-life assessment in people with Cancer, run by NCIC Clinical Trials Group at 14 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00016380, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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