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



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:October 2016
End Date:April 2020
Contact:Patricia O'Kane, BS
Email:pokane@swog.org
Phone:210-614-8808

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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)

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.

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
We found this trial at
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Duluth, Minnesota 55805
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300 N. Seventh St.
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1505 Eastland Drive
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100 E Idaho St
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915 Highland Blvd
Bozeman, Montana 59715
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160 S Adams St
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22101 Moross Rd
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2020 Central Ave
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700 West Central
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820 4th St N
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3315 N Seminary St
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Greenville, South Carolina 29615
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701 Grove Rd
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1 Jarrett White Rd
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Jonesboro, Arkansas 72401
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2316 E Meyer Blvd
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750 Avenue D West
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400 Highland Ave
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315 W. 15th St.
Liberal, Kansas 67905
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Livonia, Michigan 48154
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501 E Grant
Macomb, Illinois 61455
309-833-3503
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Manati, 00674
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Marshfield, Wisconsin 54449
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2500 Alhambra Ave
Martinez, California 94553
(925) 370-5000
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Mattoon, Illinois 61938
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Memphis, Tennessee 38120
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Memphis, Tennessee 38120
Principal Investigator: Raymond U. Osarogiagbon
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Middletown, Ohio 45042
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9601 Townline Rd
Minocqua, Wisconsin 54548
(715) 358-1000
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Marshfield Clinic Minocqua Center The Clinic was incorporated under Wisconsin law in 1916 and operates...
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Minocqua, WI
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Mount Airy, North Carolina 27030
Principal Investigator: Judith O. Hopkins
Phone: 336-718-8335
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Mount Airy, NC
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: John A. Keech
Phone: 801-507-3950
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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Nampa, Idaho 83686
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Nampa, ID
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Nashville, Tennessee 37208
Principal Investigator: Philip E. Lammers
Phone: 615-341-4716
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Nashville, TN
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200 Highway 30 West
New Albany, Mississippi 38652
Principal Investigator: Raymond U. Osarogiagbon
Phone: 901-226-1366
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New Albany, MS
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New Orleans, Louisiana 70112
Principal Investigator: Augusto C. Ochoa
Phone: 504-568-2428
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New Orleans, LA
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New York, New York 10032
Principal Investigator: Dawn L. Hershman
Phone: 212-305-6361
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New York, NY
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720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Newton, KS
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1200 Starfire Drive
Ottawa, Illinois 61350
815-431-9270
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Ottawa Clinic Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases....
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Ottawa, IL
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1100 Belk Boulevard
Oxford, Mississippi 38655
Principal Investigator: Raymond U. Osarogiagbon
Phone: 901-226-1366
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Oxford, MS
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1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Parsons, KS
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603 S 13th St
Pekin, Illinois 61554
(309) 353-0214
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Pekin Illinois CancerCare is one of the largest private oncology and hematology...
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Pekin, IL
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Peoria, IL
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