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REaCT-TC2: Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02816112
Collaborator
(none)
458
Enrollment
1
Location
2
Arms
43
Duration (Months)
10.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
458 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ciprofloxacin

Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC

Drug: Ciprofloxacin
Antibiotic
Active Comparator: G-CSF

Daily injection at home for the number of days as chosen by the treating physician

Drug: Neupogen
Granulocyte-colony stimulating factor
Other Names:
  • filgrastim

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Febrile neutropenia [2 years]

      Number of participants with febrile neutropenia

    2. Treatment-related hospitalization [2 years]

      Number of participants admitted to hospital for treatment-related reasons

    Secondary Outcome Measures

    1. Chemotherapy dose reduction [2 years]

      Number of participants who receive a dose reduction of their TC chemotherapy

    2. Chemotherapy dose delay [2 years]

      Number of participants who receive a dose delay in their TC chemotherapy

    3. Chemotherapy discontinuation [2 years]

      Number of participants who stop TC chemotherapy for any reason

    4. Microbiologic infections [2 years]

      Number of participants who have a microbiologic infection (i.e: Clostridium difficile)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ottawa Hospital Research Institute Ottawa Ontario Canada

    Sponsors and Collaborators

    • Ottawa Hospital Research Institute

    Investigators

    • Principal Investigator: Mark Clemons, MD, The Ottawa Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ottawa Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT02816112
    Other Study ID Numbers:
    • OTT 16-03
    First Posted:
    Jun 28, 2016
    Last Update Posted:
    May 27, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Neutropenia
    Febrile Neutropenia
    Ciprofloxacin

    Study Results

    No Results Posted as of May 27, 2020