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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Nausea, Vomiting, Genital Neoplasms, Female

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Time Frame:

35 days

Safety Issue:

No

Principal Investigator

Jorn Herrstedt, MD, DMSci

Investigator Role:

Study Director

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

GAND-emesis

NCT ID:

NCT01074697

Start Date:

April 2010

Completion Date:

October 2013

Related Keywords:

  • Nausea
  • Vomiting
  • Genital Neoplasms, Female
  • Randomized Controlled Trial
  • Serotonin Agonists
  • Dexamethasone
  • Receptors, Neurokinin-1
  • Radiotherapy
  • Cisplatin
  • Prevention & control
  • Neoplasms
  • Genital Neoplasms, Female
  • Nausea
  • Vomiting

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