- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02428114
A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study) (React-G)
September 27, 2017 updated by: Ottawa Hospital Research Institute
In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates for breast cancer patients.
Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, most notable being neutropenia.
Neutropenia is the presence of abnormally few white blood cells, leading to increased susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal.
Febrile neutropenia can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy.
Patients can receive medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a daily injection for 5, 7, or 10 days.
Since there is genuine uncertainty amongst healthcare professionals as to which administration schedule of Neupogen is better, investigators are performing a randomized study in which patients are put into a group by chance to give participants one of three standards of Neupogen daily injection.
Neupogen can cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of treatment this can cost $16,000 compared to a 5 day prescription which would cost half this.
In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high-cost.
This study will use an "integrated consent model" that involves an "oral consent" rather than a written informed consenting process in order to increase the number of patients who may participate while performing a study at a lower cost.
While determining the optimal treatment will improve patient comfort and acceptability, using the minimal safe duration of administration may also offer cost savings.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
142
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Kingston, Ontario, Canada
- Cancer Centre of Southeastern Ontario At Kingston General Hospital
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Ottawa, Ontario, Canada
- The Ottawa Hospital Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Newly diagnosed breast cancer patients, who will be receiving FEC-D, AC-D, dose dense AC-T, TC or TAC chemotherapy will be eligible.
Description
Inclusion Criteria:
- Histologically confirmed primary breast cancer
- Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
Exclusion Criteria:
- Contraindication to Filgrastim
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
5 days of filgrastim
Standard of care
|
7 days of filgrastim
Standard of care
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10 days of filgrastim
Standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility of performing this study will be measured with composite endpoints: physician engagement, time for local or provincial research ethics approval, accrual rates, and patient/physician compliance.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of documented febrile neutropenia (laboratory confirmation)
Time Frame: 1 year
|
1 year
|
ANC results at the end of each cycle of chemotherapy.
Time Frame: 1 year
|
1 year
|
hospital admissions
Time Frame: 1 year
|
1 year
|
percentage of patients who require chemotherapy dose delays
Time Frame: 1 year
|
1 year
|
percentage of patients who require chemotherapy dose decrease
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark Clemons, MD, The Ottawa Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Clemons M, Fergusson D, Simos D, Mates M, Robinson A, Califaretti N, Zibdawi L, Bahl M, Raphael J, Ibrahim MFK, Fernandes R, Pitre L, Aseyev O, Stober C, Vandermeer L, Saunders D, Hutton B, Mallick R, Pond GR, Awan A, Hilton J. A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer. Ann Oncol. 2020 Jul;31(7):951-957. doi: 10.1016/j.annonc.2020.04.005. Epub 2020 Apr 20.
- Ibrahim MFK, Hilton J, Mazzarello S, Fergusson D, Hutton B, Robinson A, Califaretti N, Hsu T, Gertler S, Mates M, Stober C, Vandermeer L, Mallick R, Clemons M. A multi-center pragmatic, randomized, feasibility trial comparing standard of care schedules of filgrastim administration for primary febrile neutropenia prophylaxis in early-stage breast cancer. Breast Cancer Res Treat. 2018 Apr;168(2):371-379. doi: 10.1007/s10549-017-4604-y. Epub 2017 Dec 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
April 15, 2015
First Submitted That Met QC Criteria
April 22, 2015
First Posted (Estimate)
April 28, 2015
Study Record Updates
Last Update Posted (Actual)
September 29, 2017
Last Update Submitted That Met QC Criteria
September 27, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OTT 14-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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