Breast Cancer Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

3665

Study ID:

NCT02728596

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 149 Locations for this study

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Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro Arkansas, 72401, United States
NEA Baptist Memorial Hospital
Jonesboro Arkansas, 72401, United States
Contra Costa Regional Medical Center
Martinez California, 94553, United States
Augusta University Medical Center
Augusta Georgia, 30912, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah Georgia, 31405, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Saint Luke's Mountain States Tumor Institute
Boise Idaho, 83712, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland Idaho, 83619, United States
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian Idaho, 83642, United States
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa Idaho, 83686, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls Idaho, 83301, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States
Illinois CancerCare-Canton
Canton Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States
Centralia Oncology Clinic
Centralia Illinois, 62801, United States
John H Stroger Jr Hospital of Cook County
Chicago Illinois, 60612, United States
Carle on Vermilion
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
Cancer Care Specialists of Illinois-Swansea
Swansea Illinois, 62226, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Louisiana State University Health Science Center
New Orleans Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport Louisiana, 71103, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Saint Joseph Mercy Brighton
Brighton Michigan, 48114, United States
Saint Joseph Mercy Canton
Canton Michigan, 48188, United States
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
William Beaumont Hospital - Troy
Troy Michigan, 48085, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Sanford Joe Lueken Cancer Center
Bemidji Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd Minnesota, 56401, United States
Essentia Health Cancer Center
Duluth Minnesota, 55805, United States
Sanford Thief River Falls Medical Center
Thief River Falls Minnesota, 56701, United States
Sanford Cancer Center Worthington
Worthington Minnesota, 56187, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus Mississippi, 39705, United States
Baptist Cancer Center-Grenada
Grenada Mississippi, 38901, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven Mississippi, 38671, United States
Centerpoint Medical Center LLC
Independence Missouri, 64057, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
CHI Health Saint Francis
Grand Island Nebraska, 68803, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Presbyterian Kaseman Hospital
Albuquerque New Mexico, 87110, United States
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho New Mexico, 87124, United States
Christus Saint Vincent Regional Cancer Center
Santa Fe New Mexico, 87505, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Novant Health Oncology Specialists-Kernersville
Kernersville North Carolina, 27284, United States
Novant Health Oncology Specialists-Mount Airy
Mount Airy North Carolina, 27030, United States
Novant Health Oncology Specialists-Statesville
Statesville North Carolina, 28625, United States
Novant Health Oncology Specialists-Davidson County
Thomasville North Carolina, 27360, United States
Novant Health Oncology Specialists-Wilkesboro
Wilkesboro North Carolina, 28659, United States
Novant Health Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Novant Health Oncology Specialists
Winston-Salem North Carolina, 27103, United States
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
Essentia Health Cancer Center-South University Clinic
Fargo North Dakota, 58103, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States
Dayton Physicians LLC-Miami Valley South
Centerville Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Dayton Physician LLC-Miami Valley Hospital North
Dayton Ohio, 45415, United States
Dayton Physicians LLC-Atrium
Franklin Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville Ohio, 45331, United States
Greater Dayton Cancer Center
Kettering Ohio, 45409, United States
Dayton Physicians LLC-Signal Point
Middletown Ohio, 45042, United States
Dayton Physicians LLC-Wilson
Sidney Ohio, 45365, United States
Dayton Physicians LLC-Upper Valley
Troy Ohio, 45373, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Geisinger Cancer Services-Pottsville
Pottsville Pennsylvania, 17901, United States
Community Medical Center
Scranton Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove Pennsylvania, 17870, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States
Gibbs Cancer Center-Gaffney
Gaffney South Carolina, 29341, United States
Greenville Health System Cancer Institute-Butternut
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Faris
Greenville South Carolina, 29605, United States
Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville South Carolina, 29615, United States
Greenville Health System Cancer Institute-Greer
Greer South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer South Carolina, 29651, United States
Greenville Health System Cancer Institute-Seneca
Seneca South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg South Carolina, 29307, United States
MGC Hematology Oncology-Union
Union South Carolina, 29379, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville Tennessee, 38017, United States
Integrity Oncology PLLC-Collierville
Collierville Tennessee, 38017, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis Tennessee, 38120, United States
Family Cancer Center-Memphis
Memphis Tennessee, 38120, United States
Meharry Medical College
Nashville Tennessee, 37208, United States
Logan Regional Hospital
Logan Utah, 84321, United States
Intermountain Medical Center
Murray Utah, 84107, United States
McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Dixie Medical Center Regional Cancer Center
Saint George Utah, 84770, United States
MultiCare Auburn Medical Center
Auburn Washington, 98001, United States
Swedish Cancer Institute-Edmonds
Edmonds Washington, 98026, United States
MultiCare Gig Harbor Medical Park
Gig Harbor Washington, 98335, United States
Swedish Cancer Institute-Issaquah
Issaquah Washington, 98029, United States
MultiCare Good Samaritan Hospital
Puyallup Washington, 98372, United States
Swedish Medical Center-Ballard Campus
Seattle Washington, 98107, United States
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States
Swedish Medical Center-Cherry Hill
Seattle Washington, 98122, United States
MultiCare Tacoma General Hospital
Tacoma Washington, 98405, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls Wisconsin, 54729, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire Wisconsin, 54701, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States
Marshfield Clinic - Ladysmith Center
Ladysmith Wisconsin, 54848, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, United States
Marshfield Medical Center-Rice Lake
Rice Lake Wisconsin, 54868, United States
Marshfield Clinic Stevens Point Center
Stevens Point Wisconsin, 54482, United States
Marshfield Clinic-Wausau Center
Wausau Wisconsin, 54401, United States
Marshfield Clinic - Weston Center
Weston Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids Wisconsin, 54494, United States
Doctors Cancer Center
Manati , 00674, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

3665

Study ID:

NCT02728596

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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