Breast CancerPhase 4OTT14-03NCT02173262
REaCT Integrated Consent Model to Compare Two Standard of Care Regimens
A Phase 4 study testing G-CSF and Ciprofloxacin in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- G-CSF and Ciprofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary breast cancer
- Planned TC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
- Willing to complete a survey
Who cannot join
- Contraindication to either Ciprofloxacin or G-CSF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.
- Conditions
- Breast Cancer
- Being tested
- G-CSF, Ciprofloxacin
- Keywords
- Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called granulocyte-colony stimulating factor
CiprofloxacinDrug
Also called Cipro, Cipro XR, Proquin XR
| Study group | Role | What they receive |
|---|---|---|
| G-CSF | Other | Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia. Receives: Drug: G-CSF |
| Ciprofloxacin | Other | Participants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia. Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of randomized patients in each physician's practice
The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or "opting-out" of the randomized selection compared to the overall accrual.
Measured: every 4 weeks up to 2 years
Secondary outcomes (1)
rates of febrile neutropenia
Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF
Measured: Once when the last participant completes chemotherapy up to year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Clemons, Doctor, Principal investigator, The Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173262
- Sponsor's protocol ID
- 20140380-01H
- Acronym
- OTT14-03
- Status last verified
- Oct 2017
- First submitted
- 16 Jun 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clemons M, Mazzarello S, Hilton J, Joy A, Price-Hiller J, Zhu X, Verma S, Kehoe A, Ibrahim MF, Sienkiewicz M, Stober C, Vandermeer L, Hutton B, Mallick R, Fergusson D. Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC). Support Care Cancer. 2019 Apr;27(4):1345-1354. doi: 10.1007/s00520-018-4408-6. Epub 2018 Aug 11.
PubMed 30099602
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT02173262
- Acronym / sponsor ID
- OTT14-03 / 20140380-01H
- Conditions
- Breast Cancer
- Keywords
- Breast
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF | Other | Drug: G-CSFParticipants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia. |
| Ciprofloxacin | Other | Drug: CiprofloxacinParticipants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed primary breast cancer
- Planned TC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
- Willing to complete a survey
Key exclusion criteria (1 listed)
- Contraindication to either Ciprofloxacin or G-CSF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFAlso: granulocyte-colony stimulating factor | Drug | G-CSF |
| CiprofloxacinAlso: Cipro, Cipro XR, Proquin XR | Drug | Ciprofloxacin |
Primary outcome
The percentage of randomized patients in each physician's practice
Time frame: every 4 weeks up to 2 years
The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or "opting-out" of the randomized selection compared to the overall accrual.
1 secondary outcome
rates of febrile neutropenia
Time frame: Once when the last participant completes chemotherapy up to year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 30099602Clemons M, Mazzarello S, Hilton J, Joy A, Price-Hiller J, Zhu X, Verma S, Kehoe A, Ibrahim MF, Sienkiewicz M, Stober C, Vandermeer L, Hutton B, Mallick R, Fergusson D. Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC). Support Care Cancer. 2019 Apr;27(4):1345-1354. doi: 10.1007/s00520-018-4408-6. Epub 2018 Aug 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Clemons, Doctor principal investigator
The Ottawa Hospital Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing G-CSF and Ciprofloxacin in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of randomized patients in each physician's practice (time frame: every 4 weeks up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02173262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.