Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin (GAND-emesis)

April 23, 2015 updated by: Christina Ruhlmann, Odense University Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide SA, Australia, 5000
        • RAH Cancer Centre, Royal Adelaide Hospital
  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Oncology
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Finsen Centret
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Department of Oncology, Odense University Hospital
  • Germany
      • Berlin, Germany
        • Vivantes Klinikum Neukölln
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig Holstein
  • Norway
      • Oslo, Norway, 0310
        • The Norwegian Radium Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: (abbreviated)

  1. The patient has a diagnosis cervical cancer.
  2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
  3. The patient is aged > 18 years.
  4. The patient must be both chemo- and radiotherapy (RT) naïve. NB: previously low voltage RT or electron RT for non-melanoma skin cancers is allowed.
  5. The patient is scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2 for at least five weeks.
  6. Brachy therapy is scheduled to be initiated after the third cycle of weekly cisplatin, and preferentially after the fifth week of treatment.
  7. Chemotherapy with an emetic risk potential of minimal or mild (up to 30%) is allowed on days 1-4 (see ref. 14).
  8. The patient has a WHO Performance Status of ≤ 2.

Exclusion Criteria: (abbreviated)

  1. The patient has a current malignant diagnosis other than cervical cancer, with exception of non-melanoma skin cancers.
  2. The patient is aged < 18 years.
  3. The patient is scheduled to receive less than five weeks of fractionated radiotherapy and concomitant weekly cisplatin.
  4. Brachy therapy is planned to be initiated before the third cycle of weekly cisplatin.
  5. The patient has been previously treated with radiotherapy, and/or chemotherapy, with exception of treatment with low voltage RT or electron RT for non-melanoma skin cancers .
  6. The patient has a WHO Performance Status of > 2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fosaprepitant dimeglumine
Drug: Fosaprepitant dimeglumine
Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.
Other Names:
  • Dexamethasone
  • Palonosetron
Placebo Comparator: Saline water
Drug: Placebo
Saline water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare fosaprepitant dimeglumine, palonosetron, and dexamethasone with palonosetron, dexamethasone, and placebo with respect to efficacy; the proportion of subjects with no vomiting during five weeks of radiotherapy and concomitant weekly cisplatin.
Time Frame: 35 days
35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with complete response in the 7 days following initiation of radiotherapy and concomitant weekly cisplatin.
Time Frame: 7 days
7 days
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no significant nausea during five weeks of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
Time Frame: 35 days
35 days
To compare the fosaprepitant dimeglumine regimen and the control regimen with respect to complete response in the 35 days following initiation of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
Time Frame: 35 days
35 days
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no nausea during five weeks (35 days) of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
Time Frame: 35 days
35 days
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode.
Time Frame: 0-35 days
0-35 days
To compare quality of life using the FLIE questionnaire.
Time Frame: 0-35 days
0-35 days
To compare tolerability of both regimens.
Time Frame: 0-35 days
0-35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Helsinn Healthcare SA

Investigators

  • Study Director: Jorn Herrstedt, MD, DMSci, Odense University Hospital
  • Principal Investigator: Christina Ruhlmann, MD, Odense University Hospial
  • Principal Investigator: Dorothy Keefe, MD, FRACP, Royal Adelaide Hospital
  • Principal Investigator: Petra Feyer, MD, DMSci, Vivantes Klinikum Neukölln in Berlin
  • Principal Investigator: Thomas Broe Christensen, MD, PhD, Herlev Hospital
  • Principal Investigator: Gunnar Kristensen, MD, PhD, Norwegian Radium Hospital
  • Principal Investigator: Henrik Roed, MD, DMSci, The Finsen Centre, Copenhagen University Hospital
  • Principal Investigator: Felix Hilpert, MD, DMSci, University Hospital Schleswig-Holstein
  • Principal Investigator: Jacob C Lindegaard, MD, Department of Oncology,Aarhus University Hospital, Aarhus, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAND-emesis
  • 2009-014691-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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