Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin (GAND-emesis)
This study is currently recruiting participants.
Verified January 2013 by Odense University Hospital
Sponsor:
Odense University Hospital
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 8, 2013
Last verified: January 2013
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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:
Drug Information available for:
Dexamethasone
Serotonin
Dexamethasone acetate
Dexamethasone sodium phosphate
Cisplatin
Palonosetron
Palonosetron hydrochloride
Aprepitant
Fosaprepitant
Fosaprepitant dimeglumine
U.S. FDA Resources
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 2013 |
| Estimated Primary Completion Date: | October 2013 (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:
|
| 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)
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074697
Contacts
| Contact: Jorn Herrstedt, MD, DMSci | 6541 3634 ext +45 | herrstedt@ouh.regionsyddanmark.dk |
| Contact: Christina Ruhlmann, MD | 2231 4446 ext +45 | christina.ruhlmann@ouh.regionsyddanmark.dk |
Locations
| Australia | |
| RAH Cancer Centre, Royal Adelaide Hospital | Recruiting |
| Adelaide SA, Australia, 5000 | |
| Contact: Dorothy Keefe, MD, FRACP 618 8222 5577 ext +64 | |
| Principal Investigator: Dorothy Keefe, MD, FRACP | |
| Denmark | |
| Department of Oncology | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Jacob C Lindegaard, MD, DMSci 7846 4694 ext +45 jacolind@rm.dk | |
| Principal Investigator: Jacob C Lindegaard, MD, DM.Sci. | |
| 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 | Recruiting |
| Oslo, Norway, 0310 | |
| Contact: Gunnar Kristensen, MD, PhD gunnar.kristensen@klinmed.uio.no | |
| Principal Investigator: Gunnar Kristensen, MD, PhD | |
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 8, 2013 |
| 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 May 19, 2013