Spots Global Cancer Trial Database for Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.
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Trial Identification
Brief Title: Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.
Official Title: A Prospective, Open Label, Non-comparative Trial to Determine the Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With the Docetaxel-Cyclophosphamide Regimen in Early Breast Cancer Patients
Study ID: NCT01298193
Conditions
Interventions
Study Description
Brief Summary: This is a prospective, multicenter, open label, non-comparative trial in Spain. The primary objective of this study is to determine the complete response, defined as no vomiting and no use of rescue treatment, in women with early-stage breast cancer treated with one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of CINV (Chemotherapy-induced nausea and vomiting) day 1, 5-hydroxytryptamine 3 (5-HT3) antagonist plus 3 days of dexamethasone. A second step (efficacy phase) is designed to examine the efficacy and tolerability of aprepitant in the second cycle among patients who failed to the previous CINV prevention treatment. The study will focus on early-stage chemonaive breast cancer patients receiving docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV prevention. The CINV incidence in those patients will be evaluated on the first cycle. All refractory patients, will be asked to participate in the second phase, where aprepitant on days 1, 2 and 3 will be added to their antiemetic regimen. Assuming a drop out of 5%, 212 patients will be included in the study. It is anticipated that around 48 patients will enter the efficacy phase. The duration of the study, from first patient visit to last patient visit will be approximately 21 months.
Detailed Description: Sample size We want to obtain an estimation of the percent of the patients that we assume won't have a response to the treatment against vomiting. Reviewing bibliography, we think that the percent is approximately 25%. We are going to obtain an estimation of this percent with an accuracy of +/- 6%, with a bilateral confidence level of 95% bilateral. Whit all this premises it would be needed 201 patients. Assuming a drop out of 5%, 212 patients will be included in the study. A maximum of 212 patients will be included in the trial. It is anticipated that around 48 patients will enter the efficacy phase. APPROXIMATE DURATION OF THE STUDY. Inclusion period: 18 months approximately. Estimated follow-up: December 2012 Estimated date of end of study: June 2013
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Corporació Sanitaria Parc Taulí, Sabadell, Barcelona, Spain
Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain
Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, , Spain
Centro Oncológico de Galicia, A Coruña, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Clinic i Provincial, Barcelona, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Hospital Universitario Arnau de Vilanova de Lleida, Lleida, , Spain
Complejo Hospitalario Xeral-Calde, Lugo, , Spain
Hospital Clínico Universitario San Carlos, Madrid, , Spain
Hospital Arnau de Vilanova de Valencia, Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: Study Director
Affiliation: Hospital Universitario Arnau de Vilanova
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Fundación Hospital Alcorcón
Role: STUDY_DIRECTOR
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