search
Back to results

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

Primary Purpose

Nausea, Vomiting, Genital Neoplasms, Female

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fosaprepitant dimeglumine
Placebo
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea focused on measuring Randomized Controlled Trial, Serotonin Agonists, Dexamethasone, Receptors, Neurokinin-1, Radiotherapy, Cisplatin, Prevention & control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • RAH Cancer Centre, Royal Adelaide Hospital
  • Department of Oncology
  • Rigshospitalet, Finsen Centret
  • Herlev Hospital
  • Department of Oncology, Odense University Hospital
  • Vivantes Klinikum Neukolln
  • Universitatsklinikum Schleswig Holstein
  • The Norwegian Radium Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fosaprepitant dimeglumine

Saline water

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode.
To compare quality of life using the FLIE questionnaire.
To compare tolerability of both regimens.

Full Information

First Posted
February 23, 2010
Last Updated
April 23, 2015
Sponsor
Odense University Hospital
Collaborators
Helsinn Healthcare SA
search

1. Study Identification

Unique Protocol Identification Number
NCT01074697
Brief Title
Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin
Acronym
GAND-emesis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Helsinn Healthcare SA

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Genital Neoplasms, Female
Keywords
Randomized Controlled Trial, Serotonin Agonists, Dexamethasone, Receptors, Neurokinin-1, Radiotherapy, Cisplatin, Prevention & control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fosaprepitant dimeglumine
Arm Type
Active Comparator
Arm Title
Saline water
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant dimeglumine
Other Intervention Name(s)
Palonosetron, Dexamethasone
Intervention Description
Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline water
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
To compare quality of life using the FLIE questionnaire.
Time Frame
0-35 days
Title
To compare tolerability of both regimens.
Time Frame
0-35 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (abbreviated) The patient has a diagnosis cervical cancer. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent. The patient is aged > 18 years. 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. The patient is scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2 for at least five weeks. Brachy therapy is scheduled to be initiated after the third cycle of weekly cisplatin, and preferentially after the fifth week of treatment. Chemotherapy with an emetic risk potential of minimal or mild (up to 30%) is allowed on days 1-4 (see ref. 14). The patient has a WHO Performance Status of ≤ 2. Exclusion Criteria: (abbreviated) The patient has a current malignant diagnosis other than cervical cancer, with exception of non-melanoma skin cancers. The patient is aged < 18 years. The patient is scheduled to receive less than five weeks of fractionated radiotherapy and concomitant weekly cisplatin. Brachy therapy is planned to be initiated before the third cycle of weekly cisplatin. 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 . The patient has a WHO Performance Status of > 2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorn Herrstedt, MD, DMSci
Organizational Affiliation
Odense University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christina Ruhlmann, MD
Organizational Affiliation
Odense University Hospial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dorothy Keefe, MD, FRACP
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petra Feyer, MD, DMSci
Organizational Affiliation
Vivantes Klinikum Neukölln in Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Broe Christensen, MD, PhD
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gunnar Kristensen, MD, PhD
Organizational Affiliation
Norwegian Radium Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Roed, MD, DMSci
Organizational Affiliation
The Finsen Centre, Copenhagen University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix Hilpert, MD, DMSci
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob C Lindegaard, MD
Organizational Affiliation
Department of Oncology,Aarhus University Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAH Cancer Centre, Royal Adelaide Hospital
City
Adelaide SA
ZIP/Postal Code
5000
Country
Australia
Facility Name
Department of Oncology
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Rigshospitalet, Finsen Centret
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vivantes Klinikum Neukolln
City
Berlin
Country
Germany
Facility Name
Universitatsklinikum Schleswig Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26952945
Citation
Ruhlmann CH, Christensen TB, Dohn LH, Paludan M, Ronnengart E, Halekoh U, Hilpert F, Feyer P, Kristensen G, Hansen O, Keefe D, Herrstedt J. Efficacy and safety of fosaprepitant for the prevention of nausea and emesis during 5 weeks of chemoradiotherapy for cervical cancer (the GAND-emesis study): a multinational, randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):509-518. doi: 10.1016/S1470-2045(15)00615-4. Epub 2016 Mar 4.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs