SWOG clinical trial number
S1415CD
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 Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER)
Closed
Phase
Accrual
93%
Abbreviated Title
Trial Assessing CSF Prescribing, Effectiveness and Risk (TRACER)
Status Notes
This study was permanently closed to accrual effective 4/15/20.
Activated
10/07/2016
Participants
Limited: Institutions Listed on the Title Page
Research committees
Cancer Care Delivery
Eligibility Criteria Expand/Collapse
Requirements to become a participating component:
*Site must submit application and be approved by the Study Chair in order to participate.
Patients must have a current diagnosis of breast cancer, NSCL cancer, or colorectal cancer; current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic; patients must registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage (or disease setting). Patients must not have had any systemic therapy (chemo or combination regimens) in the last 180 days just prior to registration. Prior biologic therapy, immunotherapy, tyrosine kinase inhibitors and hormonal therapy are allowed. Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; Myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted; this treatment may be neoadjuvant or adjuvant chemotherapy; patients must not be receiving or planning to receive concurrent radiation during systemic treatment. Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to E Coli derived proteins, filgrastim, pegfilgrastim. or tbo-filgrastim. Patients must be >/= 18 years of age, must be able to understand and provide information for the patient-completed forms in either English or Spanish; patients may have had a prior malignancy and must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer or investigational uses of CSF during their first 6 months after registration.
*Site must submit application and be approved by the Study Chair in order to participate.
Patients must have a current diagnosis of breast cancer, NSCL cancer, or colorectal cancer; current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic; patients must registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage (or disease setting). Patients must not have had any systemic therapy (chemo or combination regimens) in the last 180 days just prior to registration. Prior biologic therapy, immunotherapy, tyrosine kinase inhibitors and hormonal therapy are allowed. Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; Myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted; this treatment may be neoadjuvant or adjuvant chemotherapy; patients must not be receiving or planning to receive concurrent radiation during systemic treatment. Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to E Coli derived proteins, filgrastim, pegfilgrastim. or tbo-filgrastim. Patients must be >/= 18 years of age, must be able to understand and provide information for the patient-completed forms in either English or Spanish; patients may have had a prior malignancy and must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer or investigational uses of CSF during their first 6 months after registration.
Publication Information Expand/Collapse
2023
PMid: PMID36228177 | PMC number: PMC9870230
PMid: PMID37788414 | PMC number: PMC10732502
2022
PMid: PMID35365139 | PMC number: PMC8973954
Lessons from Implementing Practice-Level Cluster Randomized Studies within the NCORP Setting
PMid: PMID36279134 | PMC number: PMC9593234
Can order entry systems improve oncology practice? The TrACER Experience
PMid: PMID36378570 | PMC number: PMC9832319
Intervention non-adherence in a pragmatic randomized trial of a standardized order entry for colony stimulating factor prescribing
2019
PMid: PMID31185918 | PMC number: PMC6560751
2018
2017
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Research Committee(s)
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Phase