NCI Community Oncology Research Program - Protocol Summary
SWOG S1415CD - "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 Prophylaxis for
Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia –Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)". This trial is only open for Research Medical Center, Menorah Medical Center and Centerpoint Medical Center.
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
CCDR Clinical Trial
CANCER TYPE: Multiple Sites
RESEARCH BASE: SWOG
NCT NUMBER: NCT02728596
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 09/26/2018 (20:43:32)
Patient Brochure: VIEW PATIENT BROCHURE
UPDATED ON 09/19/2018 (20:04:43)
Colony Stimulating Factor prophylaxis in pts with any stage breast, non-small cell lung or colorectal cancer, receiving chemo w/intermediate risk for febrile neutropenia. DCP-001 Eligible
Research Medical Center has been assigned to Group 2 - Usual Care. It is up to the investigator's discretion whether or not to use PP-CSF.
- Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer. 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 (or disease setting). Patient must not have had any systemic therapy (chemotherapy or combinations regimens) in the 180 days just prior to registration. Prior biologic therapy, immunotherapy, and hormonal therapy are allowed.
- Patients must be planning to receive one of the study-allowed regimens listed in Appendix 18.1 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.
- Patient must be at least 18 years of age.
- 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.