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Recruiting NCT05780684

Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

No phase Interventional Colorectal Cancer Esophagus Cancer Appendix Cancer Small Bowel Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FOX dose-escalation algorithm.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Esophagus Cancer, Appendix Cancer, Small Bowel Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen

Overview

This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.

Interventions

  • Other FOX dose-escalation algorithm
    Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens

Primary outcome measures

  • Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen [Time frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)]
Secondary outcome measures (5)
  • Response rate to chemotherapy [Time frame: Through 6 months from Cycle 1 Day 1 of FOX regimen]
  • Progression-free survival [Time frame: Through 12 months from Cycle 1 Day 1 of FOX regimen]
  • Dose intensity of 5-FU and oxaliplatin [Time frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)]
  • Mean plasma uracil concentration [Time frame: Single treatment visit 0-30 days before Day 1 of Cycle 1 of FOX regimen, (cycle length is 14 days)]
  • 5-FU drug exposure [Time frame: Single treatment visit on Day 3 of treament Cycle 5 or Cycle 6 of FOX regimen, (cycle length is 14 days)]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)
  • Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration
  • ECOG Performance Status: 0-1

Exclusion criteria

  • Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)
  • Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)
  • Known mismatch repair deficiency or microsatellite instability-high disease
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening
  • Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator
  • Any of the following baseline laboratory abnormalities:
  • Absolute neutrophil count (ANC) < 2,500/mm3
  • Platelet count < 100,000/mm3
  • Hemoglobin < 9 g/dL
  • Creatinine > 1.5 x ULN
  • Total bilirubin > 1.5 x ULN
  • AST/ALT > 5 x ULN
  • Patients who are unable to provide informed consent
  • Patients who are pregnant or breastfeeding
  • Patients who are incarcerated, homeless, or have active substance use disorders

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dartmouth-Hitchcock Medical Center — Lebanon

Identifiers

NCT: NCT05780684 · STUDY02001873 · 22BRO873

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗