AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

RecruitingNAAges 18 Years - anyAllDartmouth-Hitchcock Medical Center
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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
๐Ÿ’Š

What it tests

  • FOX dose-escalation algorithm
๐Ÿ“

Where

1 site
Dartmouth-Hitchcock Medical Center
Lebanon, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy