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Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin

NCT01074697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2015-04-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fosaprepitant dimeglumine

Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.

DRUG

Placebo

Saline water

Sponsors & Collaborators

  • Helsinn Healthcare SA

    collaborator INDUSTRY

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jorn Herrstedt, MD, DMSci · Odense University Hospital

  • Christina Ruhlmann, MD · Odense University Hospial

  • Dorothy Keefe, MD, FRACP · Royal Adelaide Hospital

  • Petra Feyer, MD, DMSci · Vivantes Klinikum Neukölln in Berlin

  • Thomas Broe Christensen, MD, PhD · Herlev Hospital

  • Gunnar Kristensen, MD, PhD · Norwegian Radium Hospital

  • Henrik Roed, MD, DMSci · The Finsen Centre, Copenhagen University Hospital

  • Felix Hilpert, MD, DMSci · University Hospital Schleswig-Holstein

  • Jacob C Lindegaard, MD · Department of Oncology,Aarhus University Hospital, Aarhus, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Australia
  • Denmark
  • Germany
  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01074697 on ClinicalTrials.gov