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A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia (REaCT-G2)

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ClinicalTrials.gov Identifier: NCT02816164
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to which administration schedule of Neupogen is the best for patients, the investigators are performing a randomized study for which patients will receive either 5, 7 or 10 days of Neupogen. Neupogen can cost approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment, this can cost $16,000 compared to a 5 day treatment 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 oral consent model to compare 5, 7 and 10 days of Neupogen to evaluate rates of febrile neutropenia and hospitalization.

Condition or disease Intervention/treatment Phase
Early Stage Breast Cancer Drug: Neupogen Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Centre Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (REaCT-G2)
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: Neupogen for 5 days
Neupogen injection for 5 days
Drug: Neupogen
Subcutaneous injections
Other Name: Filgrastim

Active Comparator: Neupogen for 7 days
Neupogen injection for 7 days
Drug: Neupogen
Subcutaneous injections
Other Name: Filgrastim

Active Comparator: Neupogen for 10 days
Neupogen injection for 10 days
Drug: Neupogen
Subcutaneous injections
Other Name: Filgrastim




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

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


Secondary Outcome Measures :
  1. Chemotherapy dose delay [ Time Frame: 2 years ]
    Number of participants who experience a dose delay with their chemotherapy treatment

  2. Chemotherapy dose reduction [ Time Frame: 2 years ]
    Number of participants who experience a dose reduction in their chemotherapy treatment

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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02816164


Contacts
Contact: Mark Clemons, MD 613-737-7700 ext 70170 mclemons@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

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02816164     History of Changes
Other Study ID Numbers: OTT 16-04
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Neutropenia
Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs