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

NCT ID: NCT01074697

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Nausea; Vomiting; Genital Neoplasms, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Fosaprepitant dimeglumine

Group Type: ACTIVE_COMPARATOR

Fosaprepitant dimeglumine

Intervention Type: DRUG

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

Saline water

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline water

Interventions

Fosaprepitant dimeglumine

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

Intervention Type: DRUG

Placebo

Saline water

Intervention Type: DRUG

Other Intervention Names

Palonosetron; Dexamethasone

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Helsinn Healthcare SA

INDUSTRY

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christina Ruhlmann

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorn Herrstedt, MD, DMSci

Role: STUDY_DIRECTOR

Odense University Hospital

Christina Ruhlmann, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospial

Dorothy Keefe, MD, FRACP

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital

Petra Feyer, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

Vivantes Klinikum Neukölln in Berlin

Thomas Broe Christensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Gunnar Kristensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Radium Hospital

Henrik Roed, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

The Finsen Centre, Copenhagen University Hospital

Felix Hilpert, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Jacob C Lindegaard, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology,Aarhus University Hospital, Aarhus, Denmark

Locations

RAH Cancer Centre, Royal Adelaide Hospital

Adelaide SA, , Australia

Department of Oncology

Aarhus, , Denmark

Rigshospitalet, Finsen Centret

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Department of Oncology, Odense University Hospital

Odense, , Denmark

Vivantes Klinikum Neukolln

Berlin, , Germany

Universitatsklinikum Schleswig Holstein

Kiel, , Germany

The Norwegian Radium Hospital

Oslo, , Norway

Countries

Australia; Denmark; Germany; Norway

References

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.

Reference Type: DERIVED

PMID: 26952945 (View on PubMed)

Other Identifiers

2009-014691-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GAND-emesis

Identifier Type: -

Identifier Source: org_study_id