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

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01074697

Collaborator

Helsinn Healthcare SA (Industry)

246

Enrollment

Locations

Arms

Duration (Months)

30.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting Genital Neoplasms, Female	Drug: Fosaprepitant dimeglumine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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 Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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: Palonosetron Dexamethasone
Placebo Comparator: Saline water	Drug: Placebo Saline water

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:

Palonosetron

Dexamethasone

Placebo Comparator: Saline water

Drug: Placebo

Saline water

Outcome Measures

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. [35 days]

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. [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. [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. [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. [35 days]
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode. [0-35 days]
To compare quality of life using the FLIE questionnaire. [0-35 days]
To compare tolerability of both regimens. [0-35 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	RAH Cancer Centre, Royal Adelaide Hospital	Adelaide SA	Australia	5000
2	Department of Oncology	Aarhus	Denmark	8000
3	Rigshospitalet, Finsen Centret	Copenhagen	Denmark	2100
4	Herlev Hospital	Herlev	Denmark	2730
5	Department of Oncology, Odense University Hospital	Odense	Denmark	5000
6	Vivantes Klinikum Neukolln	Berlin	Germany
7	Universitatsklinikum Schleswig Holstein	Kiel	Germany	24105
8	The Norwegian Radium Hospital	Oslo	Norway	0310

Sponsors and Collaborators

Odense University Hospital
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