RECRUITING

Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-14
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05780684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * 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)
  3. * Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration
  4. * ECOG Performance Status: 0-1
  1. * Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)
  2. * Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)
  3. * Known mismatch repair deficiency or microsatellite instability-high disease
  4. * Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening
  5. * 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
  6. * Any of the following baseline laboratory abnormalities:
  7. * Absolute neutrophil count (ANC) \< 2,500/mm3
  8. * Platelet count \< 100,000/mm3
  9. * Hemoglobin \< 9 g/dL
  10. * Creatinine \> 1.5 x ULN
  11. * Total bilirubin \> 1.5 x ULN
  12. * AST/ALT \> 5 x ULN
  13. * Patients who are unable to provide informed consent
  14. * Patients who are pregnant or breastfeeding
  15. * Patients who are incarcerated, homeless, or have active substance use disorders

Contacts and Locations

Study Contact

Research Nurse
CONTACT
603-653-3637
cancer.research.nurse@hitchcock.org

Principal Investigator

Gabriel A Brooks, M.D.
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

  • Gabriel A Brooks, M.D., PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-14
Study Completion Date2026-05

Study Record Updates

Study Start Date2023-07-14
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Esophagus Cancer
  • Appendix Cancer
  • Small Bowel Cancer
  • Ampullary Cancer