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All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm.

Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy

Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy

Gabriel A Brooks, MD

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.

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 treatment with FOLFOX-type regimens. The clinical algorithm was developed by the principal investigator, and the algorithm has been iteratively revised over time based on experiences from use in routine care.

Features of the dose adjustment algorithm that differ from criteria used in clinical trial protocols and routine care include:

* At presentation for cycle 2 and 3 - the algorithm employs proactive chemotherapy dose reductions, without treatment delay, in patients with mild cytopenias (absolute neutrophil count \[ANC\] 1000-1499/mm3 and/or platelet count 75,000-99,000/mm3). In usual care, mild cytopenias during early treatment cycles do not trigger a chemotherapy dose reduction, but these early cytopenia events often lead to more severe cytopenias and subsequent delays in later treatment cycles.
* At any cycle - the algorithm employs chemotherapy dose reductions without treatment delay in patients with moderate cytopenias (ANC 750-999/mm3 and/or platelet count 50,000-74,000/mm3). In usual care, moderate cytopenias trigger both a chemotherapy treatment delay AND a subsequent dose reduction, whereas the study algorithm will introduce a dose reduction without a treatment delay.

Decisions about dose modifications and delays for reasons other than neutropenia and/or thrombocytopenia will be made at the discretion of the treating clinician, as per standard-of-care treatment.

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

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.

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)

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).

Survey-reported out-of-pocket costs will be used to estimate out-of-pocket costs associated with cytopenia-related chemotherapy treatment delays.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy	NCT04526886	Colorectal Canc... Gastric Cancer Esophageal Canc... Ampullary Cance... Small Bowel Can... Appendix Cancer	Algorithm for c...	18 Years -	Dartmouth-Hitchcock Medical Center
Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy	NCT04526886	Colorectal Canc... Gastric Cancer Esophageal Canc... Ampullary Cance... Small Bowel Can... Appendix Cancer	Algorithm for c...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for dose adjustment