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Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen Clinical research trials and Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen. Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen  Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen
Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen
For Condition: female reproductive cancer,Endocrine Cancer,Gastrointestinal Cancer,Quality of Life,nausea and vomiting
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of ondansetron with or without dexamethasone in preventing vomiting in patients with cancer who are receiving radiation therapy to the upper abdomen.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RebeccaWong, Study Chair, Princess Margaret Hospital
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H4L 2M1
Canada
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, V3V 1Z2
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Northwestern Ontario Regional Cancer Care
Thunder Bay, Ontario, P7B 6V4
Canada
Additional Information:
Study ID Numbers: CDR0000068627; CAN-NCIC-SC19
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016380
Other Female Reproductive Cancer Studies:
1. Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases
2. Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
3. Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
4. Capecitabine Combined with Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
5. Alanosine in Treating Patients With Cancer
Related Studies:
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Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen
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