CompletedNot applicableNCT02728596

S1415CD, 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.

Checked against the public recordLast updated Oct 20, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations160
SponsorSWOG Cancer Research Network
01
Study overview

What this study is about

Purpose
Health Services Research
Study type
Interventional
Phase
Not applicable
Sponsor
SWOG Cancer Research Network
Interventions being studied
Other: Preventive Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas
  • NEA Baptist Memorial HospitalJonesboro, Arkansas
  • Contra Costa Regional Medical CenterMartinez, California
  • Augusta University Medical CenterAugusta, Georgia
  • Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerSavannah, Georgia
  • Queen's Medical CenterHonolulu, Hawaii
  • Tripler Army Medical CenterHonolulu, Hawaii
  • Saint Alphonsus Cancer Care Center-BoiseBoise, Idaho
  • Saint Luke's Mountain States Tumor InstituteBoise, Idaho
  • Saint Luke's Mountain States Tumor Institute - FruitlandFruitland, Idaho
  • Saint Luke's Mountain States Tumor Institute - MeridianMeridian, Idaho
  • Saint Luke's Mountain States Tumor Institute - NampaNampa, Idaho

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 20, 2022. Always confirm current availability with the study team.

View original record ↗