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S1415CD: Prophylactic Colony Stimulating Factor Management

A Pragmatic Trial to Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as a Prophylaxis for Patients Receiving Chemotherapy With Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)

Objective

Overview

This randomized clinical trial studies prophylactic colony-stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low number of neutrophils (a type of white blood cell) in the blood. Febrile neutropenia increases the risk of infection. Colony-stimulating factors are medications sometimes given to patients receiving chemotherapy to prevent febrile neutropenia. Colony-stimulating factors are given to patients based on guidelines. Some clinics have an automated system that helps doctors decide when to prescribe them when there is a high risk of developing febrile neutropenia. Gathering information about the use of an automated system to prescribe prophylactic colony-stimulating factor may help doctors use colony stimulating factor when it is needed.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; cancer may be metastatic or non-metastatic
  • Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current diagnosis
  • Patients must be registered prior to their first cycle of systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens) for this diagnosis; if patient has had any prior systemic therapy for another malignancy, patient must not have had any systemic therapy in the 180 days just prior to registration
  • Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, or tbo-filgrastim
  • Patients must be able to understand and provide information for the patient-completed study forms in either English or Spanish
  • Patients may have had a prior malignancy
  • Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Phase: N/A

Learn More

ClinicalTrials.Gov

IRB Protocol Number
S1415CD
Principal Investigator(s)
James D. Bearden III, M.D.

Clinical Trial Categories

  • Cancer Care Delivery Research (CCDR)
Sponsor(s)
Southwest Oncology Group
How to Participate

Melyssa Foust

864-560-1035

mfoust@gibbscc.org

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