Clinical trial · Interventional
Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy
A Pragmatic, Single-Arm Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Appendix Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Small Bowel Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Arm
- description
- All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm.
- interventionNames
- Other: Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy
Primary outcomes (1)
- measure
- Unplanned Chemotherapy Treatment Delay
- timeFrame
- Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)
- description
- 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.
Secondary outcomes (2)
- measure
- Composite Safety Endpoint
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDKogan 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. PMID 31602321
- DERIVEDWright HN, Tosteson TD, Hourdequin KC, Ripple GH, Fuld AD, Dragnev KH, Amin M, Muralikrishnan S, McGrath EB, Stannard MG, Schofield LL, Lord-Halvorson S, Tosteson ANA, Brooks GA. A pragmatic, single-arm clinical trial of a dose modification algorithm for preventing cytopenia-related delays during FOLFOX chemotherapy. Support Care Cancer. 2025 Aug 8;33(9):769. doi: 10.1007/s00520-025-09784-0. PMID 40779182