S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)

PRIMARY OBJECTIVES:

I. To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to
recommended clinical practice guidelines among patients registered at intervention components
versus usual care components.

II. To compare the rate of febrile neutropenia (FN) among patients registered at intervention
components versus usual care components.

III. To compare the rate of FN among intermediate risk patients registered at intervention
components by component treatment assignment (administer PP-CSF to intermediate risk patients
versus not).

SECONDARY OBJECTIVES:

I. To compare the rate of FN among low-risk patients registered at intervention components
versus usual care components.

II. To compare the FN-related health-related quality of life (HRQOL) among low-risk patients
registered at intervention components versus usual care components.

III. To compare patient adherence to PP-CSF prescribing among patients registered at
intervention components versus usual care components.

IV. To compare patient knowledge of the indications for, efficacy of, and side effects
associated with PP-CSF between the initiation and conclusion of the first cycle of
myelosuppressive systemic therapy among patients registered at intervention components versus
usual care components.

V. To compare the proportion of patients completing the initial systemic therapy regimen at
planned duration and at planned dose intensity among patients registered at intervention
components versus usual care components.

VI. To compare antibiotic use both as prophylaxis and as treatment for FN among patients
registered at intervention components versus usual care components.

VII. To compare the rate of FN-related emergency department visits and hospitalizations among
intermediate risk patients registered to Intervention components by component treatment
assignment (administer PP-CSF to intermediate risk patients versus not).

VIII. To compare the FN-related health-related quality of life (HRQOL) among intermediate
risk patients registered to intervention components by component treatment assignment
(administer PP-CSF to intermediate risk patients versus not).

IX. To compare overall survival among intermediate risk patients registered to intervention
components by component treatment assignment (administer PP-CSF to intermediate risk patients
versus not).

TERTIARY OBJECTIVES:

I. To characterize and descriptively report the differences among cohort components and the
intervention and usual care components.

II. To evaluate the time to invasive recurrence in non-metastatic patients by component
treatment assignment

OUTLINE: Patients are randomized to 1 of 4 clinic groups.

CLINIC GROUP 1 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN
receive CSF based on the automated system recommendations. The automated system suggests that
CSFs not be used for drugs that have a low risk of FN.

CLINIC GROUP 2 (CLINIC WITH NO AUTOMATED SYSTEM): Patients receive CSF based on clinical
practice guidelines.

CLINIC GROUP 3 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high or moderate risk of
developing FN receive CSF based on the automated system recommendations. The automated system
suggests that CSFs not be used for drugs that have a low risk of FN.

CLINIC GROUP 4 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN
receive CSF based on the automated system recommendations. The automated system suggests that
CSF not be used for drugs that have a moderate risk of FN.

After completion of study treatment, patients are followed up for 12 months.

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