N/A
N=52
Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy
Colorectal Cancer · Gastric Cancer · Esophageal Cancer · Ampullary Cancer · Small Bowel Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04526886 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Unplanned Chemotherapy Treatment Delay — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unplanned Chemotherapy Treatment Delay |
16 | — |
| SECONDARY Composite Safety Endpoint |
3 | — |
| SECONDARY Relative Dose Intensity of Chemotherapy |
0.913; 0.850; 0.643 | — |
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 adjustment algorithm for reducing unplanned delays in patients receiving FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)-type chemotherapy, while maintaining acceptable chemotherapy dose-intensity.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04526886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.