An interventional study of Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy in Colorectal Cancer, Gastric Cancer and Esophageal Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
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:
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 52 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm.
Other: Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy
Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy
Unplanned Chemotherapy Treatment Delay
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.
Time frame: Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)
Composite Safety Endpoint
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)
Time frame: Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)
Relative Dose Intensity of Chemotherapy
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).
Time frame: Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)
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.
| Milestone | Study Arm |
|---|---|
| Started | 52 |
| Completed | 48 |
| Not completed | 4 |
| Withdrew: Physician decision | 4 |
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.
| Participants | Evaluable Participants |
|---|---|
| Unplanned Chemotherapy Treatment Delay | 16 |
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)
| Participants | All Enrolled Participants |
|---|---|
| Composite Safety Endpoint | 3 |
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).
| Percentage | Participants Completing Six Cycles of FOLFOX |
|---|---|
| 5-FU infusion | 0.913 (0.875 to 1.00) |
| Oxaliplatin | 0.850 (0.789 to 0.968) |
| 5-FU bolus | 0.643 (0.455 to 0.917) |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Enrolled Participants | 1/52 (1.9%) | 0/52 (0%) | 4/52 (7.7%) |
| Event | All Enrolled Participants |
|---|---|
| Neutropenia, Grade 4Blood and lymphatic system disorders | 4/52 |
| Age, Categorical(Participants) | Evaluable Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 26 |
| Age, Continuous(Years) | Evaluable Subjects |
|---|---|
| Median | 66 (41 to 81) |
| Sex: Female, Male(Participants) | Evaluable Subjects |
|---|---|
| Female | 24 |
| Male | 24 |
| Region of Enrollment(Participants) | Evaluable Subjects |
|---|---|
| United States | 48 |
| Race (NIH/OMB)(Participants) | Evaluable Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 47 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
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Dartmouth-Hitchcock Medical Center