Colorectal Cancer Clinical Trial
Official title:
A Pragmatic, Single-Arm Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy
NCT number | NCT04526886 |
Other study ID # | D20125 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 15, 2020 |
Est. completion date | March 7, 2023 |
Verified date | May 2023 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is testing an intervention of an investigator-developed chemotherapy dose adjustment algorithm. The primary objective of this study is to evaluate the effectiveness of the chemotherapy dose adjustment algorithm for reducing unplanned delays in patients receiving FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)-type chemotherapy, while maintaining acceptable chemotherapy dose-intensity.
Status | Completed |
Enrollment | 54 |
Est. completion date | March 7, 2023 |
Est. primary completion date | March 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age greater than 18 - Diagnosis of adenocarcinoma of the gastrointestinal tract (to include cancers of the colorectum, stomach, esophagus, appendix, and small bowel) - The treating oncologist's recommendation must be for six or more cycles of standard-dose mFOLFOX chemotherapy (with or without concurrent bevacizumab, cetuximab, panitumumab, or trastuzumab). Intent of treatment may be either curative or palliative in nature. - Completion of day 1 of cycle 1 of standard-of-care FOLFOX chemotherapy Exclusion Criteria: - Prior receipt of systemic chemotherapy in the 12 months prior to day 1 of cycle 1 of mFOLFOX (other than radiation-sensitizing chemotherapy) - History of baseline neutropenia; defined as neutrophil count <1500 in the 30 days preceding planned day 1 of cycle 1 of mFOLFOX - History of baseline thrombocytopenia; defined as platelet count <100,000) in the 30 days preceding planned day 1 of cycle 1 of mFOLFOX - Patients with a history of an uncorrected bleeding condition that would preclude safe use of the dose adjustment algorithm, in the judgement of the enrolling investigator - Patients who have started a new prescription anticoagulant (e.g. warfarin, heparin derivatives, or direct oral anticoagulants) in the 14 days preceding day 1 of cycle 1 of mFOLFOX - Patients who are unable to provide informed consent - Pregnant women |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Kogan LG, Davis SL, Brooks GA. Treatment delays during FOLFOX chemotherapy in patients with colorectal cancer: a multicenter retrospective analysis. J Gastrointest Oncol. 2019 Oct;10(5):841-846. doi: 10.21037/jgo.2019.07.03. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unplanned chemotherapy treatment delay | Number of patients with any interruption of chemotherapy leading to a cycle length of >18 days that is not anticipated as of day 3 of the preceding treatment cycle. | Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days) | |
Secondary | Composite safety endpoint | Number of patients meeting the composite endpoint of 1) febrile neutropenia (grade 3 or 4), 2) major bleeding with concurrent grade 3 thrombocytopenia (platelet count <50,000/mm3), 3) CTCAE grade 4 neutropenia (ANC <500/mm3), and/or 4) CTCAE grade 4 thrombocytopenia (platelet count <25,000/mm3) | Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days) | |
Secondary | Relative dose intensity of chemotherapy | Relative dose intensity (RDI) of chemotherapy. RDI is defined as (planned cumulative dose/cumulative administered dose)*(actual duration/planned duration). RDI will be calculated separately for each component of the FOLFOX regimen (5-FU bolus, 5-FU infusion, oxaliplatin). | Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days) | |
Secondary | Out of pocket costs associated with chemotherapy treatment visits | Survey-reported out-of-pocket costs will be used to estimate out-of-pocket costs associated with cytopenia-related chemotherapy treatment delays. | Single chemotherapy treatment visit on day 1 of cycle 3, 4, or 5 (cycle length is 14 days) |
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