Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01074697




Registration number
NCT01074697
Ethics application status
Date submitted
23/02/2010
Date registered
24/02/2010
Date last updated
24/04/2015

Titles & IDs
Public title
Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin
Scientific 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.
Secondary ID [1] 0 0
2009-014691-21
Secondary ID [2] 0 0
GAND-emesis
Universal Trial Number (UTN)
Trial acronym
GAND-emesis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea 0 0
Vomiting 0 0
Genital Neoplasms, Female 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fosaprepitant dimeglumine
Treatment: Drugs - Placebo

Active comparator: Fosaprepitant dimeglumine -

Placebo comparator: Saline water -


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

Treatment: Drugs: Placebo
Saline water
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
35 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
35 days
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
35 days
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
35 days
Secondary outcome [5] 0 0
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode.
Timepoint [5] 0 0
0-35 days
Secondary outcome [6] 0 0
To compare quality of life using the FLIE questionnaire.
Timepoint [6] 0 0
0-35 days
Secondary outcome [7] 0 0
To compare tolerability of both regimens.
Timepoint [7] 0 0
0-35 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
RAH Cancer Centre, Royal Adelaide Hospital - Adelaide SA
Recruitment postcode(s) [1] 0 0
5000 - Adelaide SA
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
Denmark
State/province [3] 0 0
Herlev
Country [4] 0 0
Denmark
State/province [4] 0 0
Odense
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Germany
State/province [6] 0 0
Kiel
Country [7] 0 0
Norway
State/province [7] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Other
Name
Odense University Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Helsinn Healthcare SA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jorn Herrstedt, MD, DMSci
Address 0 0
Odense University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01074697