Trial Outcomes & Findings for Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy (NCT NCT04526886)

Last Updated: 2025-10-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)

Results posted on

2025-10-06

Participant Flow

Participants were recruited at the Dartmouth Cancer Center from the Lebanon, NH, St. Johnsbury, VT, and Nashua, NH, clinic sites between September 14, 2020 and December 14, 2022.

Participant milestones

Participant milestones
Measure	Study Arm All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm. Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy: Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy
Overall Study STARTED	52
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Arm All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm. Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy: Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy
Overall Study Physician Decision	4

Baseline Characteristics

Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evaluable Subjects n=48 Participants All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm. Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy: Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Age, Continuous	66 Years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)

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.

Outcome measures

Outcome measures
Measure	Evaluable Participants n=48 Participants All study participants evaluable for the primary outcome
Unplanned Chemotherapy Treatment Delay	16 Participants

SECONDARY outcome

Timeframe: Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)

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)

Outcome measures

Outcome measures
Measure	Evaluable Participants n=52 Participants All study participants evaluable for the primary outcome
Composite Safety Endpoint	3 Participants

SECONDARY outcome

Timeframe: Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)

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).

Outcome measures

Outcome measures
Measure	Evaluable Participants n=45 Participants All study participants evaluable for the primary outcome
Relative Dose Intensity of Chemotherapy 5-FU infusion	0.913 Percentage Interval 0.875 to 1.0
Relative Dose Intensity of Chemotherapy Oxaliplatin	0.850 Percentage Interval 0.789 to 0.968
Relative Dose Intensity of Chemotherapy 5-FU bolus	0.643 Percentage Interval 0.455 to 0.917

Adverse Events

All Enrolled Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Enrolled Participants n=52 participants at risk All participants enrolled in the study - includes participants who were not evaluable for the primary study outcome
Blood and lymphatic system disorders Neutropenia, Grade 4	7.7% 4/52 • Number of events 4 • Adverse event data were collected between the date of registration and the day 1 of the cycle 6 of FOLFOX chemotherapy (14-day planned cycle length).

Additional Information

Gabriel Brooks

Dartmouth Hitchcock Medical Center

Phone: (603) 650-4344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place