Status:
COMPLETED
Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Colorectal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The study intervention will involve implementation of a clinical algorithm to guide chemotherapy dose reductions and treatment delays in patients with neutropenia and/or thrombocytopenia during treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04526886
Start Date
October 15 2020
End Date
March 7 2023
Last Update
October 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756