Evidence map›Paper›PMID 40779182›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

A pragmatic, single-arm clinical trial of a dose modification algorithm for preventing cytopenia-related delays during FOLFOX chemotherapy.

Heather N Wright, Tor D Tosteson, Kathryn C Hourdequin, Gregory H Ripple, Alexander D Fuld, Konstantin H Dragnev, Manik Amin, Sivraj Muralikrishnan, Elizabeth B McGrath, Maureen G Stannard and 4 more

Registry-linked trialAbstract readPragmatic Clinical Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04526886 (A Pragmatic, Single-Arm Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04526886 nacompletednot on this map

A Pragmatic, Single-Arm Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy

TypeinterventionalSponsorDartmouth-Hitchcock Medical CenterRan2020 to 2023Enrolled52ConditionsColorectal Cancer, Gastric Cancer, Esophageal Cancer, Ampullary CancerArmsAlgorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Heather N WrightDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Tor D TostesonDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Kathryn C HourdequinDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Gregory H RippleDartmouth Cancer Center, St. Johnsbury, VT, USA.
Alexander D FuldDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Konstantin H DragnevDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Manik AminUniversity of Chicago Comprehensive Cancer Center, Chicago, IL, USA.
Sivraj MuralikrishnanDepartment of Hematology and Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Elizabeth B McGrathDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Maureen G StannardDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Lora L SchofieldDartmouth Cancer Center, St. Johnsbury, VT, USA.
Sierra Lord-HalvorsonDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Anna N A TostesonDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA.
Gabriel A BrooksDartmouth Cancer Center, 1 Medical Center Drive, Lebanon, NH, 03756, USA. gabriel.a.brooks@hitchcock.org.ORCID http://orcid.org/0000-0003-3984-9995

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Fred W Kolling IV · 1985 to 2026
$91.3M
NCI NIH HHS P30 CA023108NIH HHS 5P30CA023108
6 · The paper itself

Abstract

purposeUnplanned delays are common during FOLFOX chemotherapy. We evaluated a novel FOLFOX dose modification algorithm designed to reduce unplanned delays while maintaining dose intensity.

methodsWe conducted a pragmatic, single-arm clinical trial to evaluate PAGODA, a proactive graduated dose modification algorithm for FOLFOX chemotherapy (NCT04526886). The algorithm prescribes chemotherapy dose reductions and delays based on absolute neutrophil count (ANC) and platelet count. Patients receiving FOLFOX-based chemotherapy were eligible. Participants received standard chemotherapy doses in cycle 1 (bolus 5-FU 400 mg/m

resultsThere were 48 evaluable participants. The median age was 66, and 50% were female. The most common primary cancer sites were colorectal (n = 31) and gastroesophageal (n = 12). Sixteen of 48 subjects had any unplanned delay before completing cycle 6 (33%, 95% CI 0.22-0.47, p = 0.18 for comparison with the historical proportion) and seven subjects had any cytopenia-related delay (15%, CI 0.07-0.27). Seven cycles were delivered without delay with an ANC of 750-999/µl. The mean chemotherapy RDIs were: oxaliplatin, 86%; infusional 5-FU, 92%; and bolus 5-FU, 65%.

conclusionsThe PAGODA dose modification algorithm was safe and was associated with a low rate of cytopenia-related delays. Further intervention refinement and testing may help to reduce unplanned delays and attendant time toxicity.

trial registrationRegistered at ClinicalTrials.gov on August 21, 2020. CLINICALTRIALS: gov ID: NCT04526886.

Indexed as

AlgorithmsAntineoplastic Combined Chemotherapy ProtocolsCytopeniaNeoplasmsAdultAgedDose-Response Relationship, DrugFemaleFluorouracilHumansLeucovorinMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinPlatelet CountFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatinFOLFOX chemotherapyRelative dose intensityUnplanned delay

Identifiers

PMID40779182
PMCPMC12439427

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.