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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00016380 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: dexamethasone Drug: ondansetron Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| 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 Start Date: | February 2001 |
OBJECTIVES:
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.
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cancer patients who are scheduled to receive radiotherapy within the next 3 weeks
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Fraser Valley Cancer Centre at British Columbia Cancer Agency | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Northwestern Ontario Regional Cancer Care | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H4L 2M1 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| CHUS-Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Study Chair: | Rebecca Wong, MD | Princess Margaret Hospital, Canada |
More Information
| Study ID Numbers: | CDR0000068627, CAN-NCIC-SC19 |
| Study First Received: | May 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00016380 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Dexamethasone Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Serotonin Antagonists Therapeutic Uses Antipruritics Ondansetron |
Dermatologic Agents Dexamethasone acetate Tranquilizing Agents Antineoplastic Agents, Hormonal Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Glucocorticoids Pharmacologic Actions Serotonin Agents Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |