Spots Global Cancer Trial Database for Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin
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Trial Identification
Brief Title: Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin
Official Title: A Multinational, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Tolerability of Palonosetron and Dexamethasone Plus Fosaprepitant or Placebo in Patients Receiving Radiotherapy and Weekly Cisplatin.
Study ID: NCT01074697
Study Description
Brief Summary: GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy. The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
RAH Cancer Centre, Royal Adelaide Hospital, Adelaide SA, , Australia
Department of Oncology, Aarhus, , Denmark
Rigshospitalet, Finsen Centret, Copenhagen, , Denmark
Herlev Hospital, Herlev, , Denmark
Department of Oncology, Odense University Hospital, Odense, , Denmark
Vivantes Klinikum Neukolln, Berlin, , Germany
Universitatsklinikum Schleswig Holstein, Kiel, , Germany
The Norwegian Radium Hospital, Oslo, , Norway
Contact Details
Name: Jorn Herrstedt, MD, DMSci
Affiliation: Odense University Hospital
Role: STUDY_DIRECTOR
Name: Christina Ruhlmann, MD
Affiliation: Odense University Hospial
Role: PRINCIPAL_INVESTIGATOR
Name: Dorothy Keefe, MD, FRACP
Affiliation: Royal Adelaide Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Petra Feyer, MD, DMSci
Affiliation: Vivantes Klinikum Neukölln in Berlin
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Broe Christensen, MD, PhD
Affiliation: Herlev Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Gunnar Kristensen, MD, PhD
Affiliation: Norwegian Radium Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Henrik Roed, MD, DMSci
Affiliation: The Finsen Centre, Copenhagen University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Felix Hilpert, MD, DMSci
Affiliation: University Hospital Schleswig-Holstein
Role: PRINCIPAL_INVESTIGATOR
Name: Jacob C Lindegaard, MD
Affiliation: Department of Oncology,Aarhus University Hospital, Aarhus, Denmark
Role: PRINCIPAL_INVESTIGATOR
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