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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Odense University Hospital
Sponsor:
Collaborator:
Helsinn Healthcare SA
Information provided by (Responsible Party):
Christina Ruhlmann, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01074697
First received: February 23, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Nausea
Vomiting
Genital Neoplasms, Female
Drug: Fosaprepitant dimeglumine
Drug: Placebo
Phase 3

Study Type: 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
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.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

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. [ Time Frame: 35 days ] [ Designated as safety issue: No ]

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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare quality of life using the FLIE questionnaire. [ Time Frame: 0-35 days ] [ Designated as safety issue: No ]
  • To compare tolerability of both regimens. [ Time Frame: 0-35 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: April 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Fosaprepitant dimeglumine
  • Palonosetron
  • Dexamethasone
Placebo Comparator: Saline water Drug: Placebo
Saline water

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074697

Contacts
Contact: Jorn Herrstedt, MD, DMSci 6541 3634 ext +45 herrstedt@rsyd.dk
Contact: Christina Ruhlmann, MD 2231 4446 ext +45 christina.ruhlmann@rsyd.dk

Locations
Australia
RAH Cancer Centre, Royal Adelaide Hospital Terminated
Adelaide SA, Australia, 5000
Denmark
Department of Oncology Terminated
Aarhus, Denmark, 8000
Rigshospitalet, Finsen Centret Recruiting
Copenhagen, Denmark, 2100
Contact: Line Hammer Dohn, MD       line.hammer.dohn@rh.regionh.dk   
Principal Investigator: Henrik Roed, MD, DMSci         
Sub-Investigator: Line Hammer Dohn, MD         
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Thomas Broe Christensen, MD, PhD    4488 3096 ext +45      
Principal Investigator: Thomas Broe Christensen, MD, PhD         
Department of Oncology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Christina Ruhlmann, MD    2231 4446 ext +45    christina.ruhlmann@ouh.regionsyddanmark.dk   
Contact: Jorn Herrstedt, MD, DMSci       herrstedt@ouh.regionsyddanmark.dk   
Principal Investigator: Christina Ruhlmann, MD         
Sub-Investigator: Jorn Herrstedt, MD, DMSci         
Germany
Vivantes Klinikum Neukolln Recruiting
Berlin, Germany
Contact: Petra Feyer, professor         
Sub-Investigator: Maike de Wit, professor         
Principal Investigator: Petra Feyer, professor         
Universitatsklinikum Schleswig Holstein Recruiting
Kiel, Germany, 24105
Contact: Felix Hilpert, MD         
Principal Investigator: Felix Hilpert, MD         
Sub-Investigator: Rebecca Ruhwald, MD         
Norway
The Norwegian Radium Hospital Terminated
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 of Schleswig-Holstein
Principal Investigator: Jacob C Lindegaard, MD Department of Oncology,Aarhus University Hospital, Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Christina Ruhlmann, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01074697     History of Changes
Other Study ID Numbers: GAND-emesis, 2009-014691-21
Study First Received: February 23, 2010
Last Updated: January 7, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Australia: Human Research Ethics Committee
Germany: Ethics Commission
Norway: Ethics Committee

Keywords provided by Odense University Hospital:
Randomized Controlled Trial
Serotonin Agonists
Dexamethasone
Receptors, Neurokinin-1
Radiotherapy
Cisplatin
Prevention & control

Additional relevant MeSH terms:
Neoplasms
Genital Neoplasms, Female
Nausea
Vomiting
Urogenital Neoplasms
Neoplasms by Site
Signs and Symptoms, Digestive
Signs and Symptoms
Cisplatin
Dexamethasone
Dexamethasone acetate
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Palonosetron
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 20, 2014