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

Completed · Not applicable

Conditions studied: Febrile Neutropenia, Stage 0 Breast Cancer, Stage 0 Colorectal Cancer, Stage 0 Non-Small Cell Lung Cancer, Stage I Colorectal Cancer, Stage IA Breast Cancer, Stage IA Non-Small Cell Lung Carcinoma, Stage IB Breast Cancer, Stage IB Non-Small Cell Lung Carcinoma, Stage IIA Breast Cancer, Stage IIA Colorectal Cancer, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Breast Cancer, Stage IIB Colorectal Cancer, Stage IIB Non-Small Cell Lung Carcinoma, Stage IIC Colorectal Cancer, Stage IIIA Breast Cancer, Stage IIIA Colorectal Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Colorectal Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IIIC Colorectal Cancer, Stage IV Breast Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT02728596

Run by

SWOG Cancer Research Network

People needed

3665

Starts

2016-10-07

Expected to finish

2021-08-12

Last updated by the study team

2022-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Tripler Army Medical Center — Honolulu, Hawaii, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Saint Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• Saint Luke's Mountain States Tumor Institute - Fruitland — Fruitland, Idaho, United States
• Saint Luke's Mountain States Tumor Institute - Meridian — Meridian, Idaho, United States
• Saint Luke's Mountain States Tumor Institute - Nampa — Nampa, Idaho, United States
• Saint Luke's Mountain States Tumor Institute-Twin Falls — Twin Falls, Idaho, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Illinois CancerCare-Carthage — Carthage, Illinois, United States
• Centralia Oncology Clinic — Centralia, Illinois, United States
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States
• Carle on Vermilion — Danville, Illinois, United States
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
• Carle Physician Group-Effingham — Effingham, Illinois, United States
• Crossroads Cancer Center — Effingham, Illinois, United States
• Illinois CancerCare-Eureka — Eureka, Illinois, United States
• Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
• Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
• Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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