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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    50
  • sponsor
    Dartmouth-Hitchcock Medical Center
Updated on 6 November 2021
cancer
fluorouracil
oxaliplatin
panitumumab
leucovorin
bevacizumab
folfox regimen
cetuximab
trastuzumab
cancer chemotherapy
adenocarcinoma

Summary

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.

Description

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.

Details
Condition Ampullary Carcinoma, Small Bowel Cancer, Esophageal Carcinoma, Head and Neck Cancer, Colon Cancer Screening, Esophageal Diseases, colorectal neoplasm, oesophageal carcinoma, head and neck cancer, Stomach Discomfort, Stomach Cancer, Esophageal Disorders, Ampullary Cancer, cancer of the esophagus, Gastric Cancer, Rectal disorder, tumors, colorectal, Rectal Disorders, colorectal cancers, Colon cancer; rectal cancer, Gastropathy, Esophageal Cancer, esophagus cancer, colorectal tumor, gastric cancers, Colorectal Cancer, carcinoma of ampulla of vater, Malignant neoplasm of appendix, oesophageal cancer, Ampulla of Vater Cancer, cancer, colorectal, Gastric Carcinoma, small intestinal cancer
Treatment Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy
Clinical Study IdentifierNCT04526886
SponsorDartmouth-Hitchcock Medical Center
Last Modified on6 November 2021

Eligibility

Yes No Not Sure

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
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