N/A
N=3,605
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
Febrile Neutropenia · Stage 0 Breast Cancer · Stage 0 Colorectal Cancer · Stage 0 Non-Small Cell Lung Cancer · Stage I Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02728596 ↗Enrolled (actual)
3,605
Serious AEs
0.2%
Results posted
Oct 2022
Primary outcome: Primary: Percentage of Participants With CSF Prescribed as Primary Prophylaxis — 8.3; 5.5; 7.2; 5.3 percentage of participants — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preventive Intervention (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With CSF Prescribed as Primary Prophylaxis |
8.3; 5.5; 7.2; 5.3; 37.1; 18.8 | 0.21 |
| PRIMARY Incidence of Febrile Neutropenia |
1.7; 0.8; 1.6; 1.5; 5.9; 2.9 | 0.26 |
| PRIMARY Incidence of Febrile Neutropenia Among Intermediate Risk Participants |
5.9; 2.9; 3.7; 3.7 | 0.74 |
| SECONDARY Incidence of Febrile Neutropenia Among Low Risk Participants |
1.8; 0.8; 1.8; 1.5 | — |
| SECONDARY FN-related Health-Related Quality of Life (HRQOL) Among Low Risk Participants |
— | — |
| SECONDARY Participant Adherence Rates to PP-CSF Prescription |
— | — |
| SECONDARY Change in Participant Knowledge of PP-CSF Indications |
— | — |
| SECONDARY Proportion Completing Initial Systemic Therapy Regimen: a) at Planned Duration and b) at Planned Dose Intensity (Clinical) |
— | — |
| SECONDARY Prophylactic and FN-Related Antibiotic Use |
— | — |
| SECONDARY Rate of FN-Related Emergency Department Visits and Hospitalizations |
— | — |
| SECONDARY FN-related Health-Related Quality of Life (HRQOL) Among Intermediate Risk Participants |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the 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 be registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage 9or disease setting).
- Patients must not have had any systemic therapy (chemotherapy or combination regimens) in the 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 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 during their first 6 months after registration
- 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
Data sourced from ClinicalTrials.gov (NCT02728596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.