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

This study is currently recruiting participants.
Verified September 2016 by Ottawa Hospital Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02816112
First Posted: June 28, 2016
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose

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 Intervention Phase
Early Stage Breast Cancer Drug: Ciprofloxacin Drug: Neupogen Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Febrile neutropenia [ Time Frame: 2 years ]
    Number of participants with febrile neutropenia

  • Treatment-related hospitalization [ Time Frame: 2 years ]
    Number of participants admitted to hospital for treatment-related reasons


Secondary Outcome Measures:
  • Chemotherapy dose reduction [ Time Frame: 2 years ]
    Number of participants who receive a dose reduction of their TC chemotherapy

  • Chemotherapy dose delay [ Time Frame: 2 years ]
    Number of participants who receive a dose delay in their TC chemotherapy

  • Chemotherapy discontinuation [ Time Frame: 2 years ]
    Number of participants who stop TC chemotherapy for any reason

  • Microbiologic infections [ Time Frame: 2 years ]
    Number of participants who have a microbiologic infection (i.e: Clostridium difficile)


Estimated Enrollment: 176
Study Start Date: September 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: filgrastim

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816112


Contacts
Contact: Mark Clemons, MD mclemons@toh.on.ca
Contact: Meri-Jo Thompson, MSc, MBA methompson@toh.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada
Principal Investigator: Mark Clemons, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Mark Clemons, MD The Ottawa Hospital
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02816112     History of Changes
Other Study ID Numbers: OTT 16-03
First Submitted: June 24, 2016
First Posted: June 28, 2016
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IDP available.

Additional relevant MeSH terms:
Neutropenia
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Antibiotics, Antitubercular
Lenograstim
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs