Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia (REaCT-TC2)
Primary Purpose
Early Stage Breast Cancer
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Ciprofloxacin
Neupogen
Sponsored by
About this trial
This is an interventional treatment trial for Early Stage Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed primary breast cancer
- Planned TC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
Exclusion Criteria:
- Contraindication to either Ciprofloxacin or G-CSF
Sites / Locations
- The Ottawa Hospital Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ciprofloxacin
G-CSF
Arm Description
Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC
Daily injection at home for the number of days as chosen by the treating physician
Outcomes
Primary Outcome Measures
Febrile neutropenia
Number of participants with febrile neutropenia
Treatment-related hospitalization
Number of participants admitted to hospital for treatment-related reasons
Secondary Outcome Measures
Chemotherapy dose reduction
Number of participants who receive a dose reduction of their TC chemotherapy
Chemotherapy dose delay
Number of participants who receive a dose delay in their TC chemotherapy
Chemotherapy discontinuation
Number of participants who stop TC chemotherapy for any reason
Microbiologic infections
Number of participants who have a microbiologic infection (i.e: Clostridium difficile)
Full Information
NCT ID
NCT02816112
First Posted
June 24, 2016
Last Updated
May 26, 2020
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02816112
Brief Title
Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia
Acronym
REaCT-TC2
Official Title
A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100.
The investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
458 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ciprofloxacin
Arm Type
Active Comparator
Arm Description
Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC
Arm Title
G-CSF
Arm Type
Active Comparator
Arm Description
Daily injection at home for the number of days as chosen by the treating physician
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Antibiotic
Intervention Type
Drug
Intervention Name(s)
Neupogen
Other Intervention Name(s)
filgrastim
Intervention Description
Granulocyte-colony stimulating factor
Primary Outcome Measure Information:
Title
Febrile neutropenia
Description
Number of participants with febrile neutropenia
Time Frame
2 years
Title
Treatment-related hospitalization
Description
Number of participants admitted to hospital for treatment-related reasons
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Chemotherapy dose reduction
Description
Number of participants who receive a dose reduction of their TC chemotherapy
Time Frame
2 years
Title
Chemotherapy dose delay
Description
Number of participants who receive a dose delay in their TC chemotherapy
Time Frame
2 years
Title
Chemotherapy discontinuation
Description
Number of participants who stop TC chemotherapy for any reason
Time Frame
2 years
Title
Microbiologic infections
Description
Number of participants who have a microbiologic infection (i.e: Clostridium difficile)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed primary breast cancer
Planned TC chemotherapy
≥19 years of age
Able to provide verbal consent
Exclusion Criteria:
Contraindication to either Ciprofloxacin or G-CSF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Clemons, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IDP available.
Learn more about this trial
Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia
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