5-Fluorouracil for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of two different schedules of the chemotherapy drug 5-Fluorouracil (5-FU) for treating head and neck cancer that has returned or spread after initial treatments. The researchers aim to determine if these methods can shrink tumors in patients whose cancer has progressed despite previous platinum-based and PD-1 inhibitor therapies. One group will receive 5-FU over two days every two weeks, while another will receive it over four days every three weeks. The trial seeks participants with specific types of head and neck cancer who have not responded to certain treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that 5-Fluorouracil (5-FU) is a widely used chemotherapy drug for treating various cancers, including those of the head and neck. Doctors have used it for many years, and it is well-known in the medical community.
Studies have found that about 30% of patients experience some side effects. The most common ones include fatigue, nausea, diarrhea, and mouth sores. Some patients might also experience heart-related issues, but this is less common, occurring in about 1% to 20% of cases.
The risk of severe side effects can depend on genetic factors, meaning some individuals might be more susceptible due to their genetic makeup. Overall, while 5-FU can cause side effects, it remains a well-researched treatment with a known safety record.12345Why are researchers excited about this trial's treatment for head and neck cancer?
5-Fluorouracil (5-FU) is unique because it offers different dosing schedules that could improve how head and neck cancer is managed. Unlike typical treatments that may involve more frequent hospital visits, 5-FU allows for flexible administration either every two or three weeks, potentially improving patient convenience and quality of life. Researchers are excited because these dosing strategies might balance effectiveness with reduced side effects, offering a tailored approach to cancer care.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
Research has shown that 5-Fluorouracil (5-FU) can effectively treat head and neck cancers. One study found that 38% of patients responded to the treatment, with 19% experiencing a noticeable reduction or complete disappearance of their tumors, indicating significant tumor shrinkage for many patients. Another study suggested that these tumors may struggle to break down 5-FU, potentially enhancing its effectiveness. In this trial, participants will receive one of two randomized dosing schedules of 5-FU. Adjusting the dosage to suit individual patients has also been linked to better outcomes in those with recurring head and neck cancers. Overall, these studies support the potential of 5-FU as a treatment for this type of cancer.16789
Who Is on the Research Team?
Christine Auberle, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 5-FU in two different regimens: Arm 1 with 2 days every 2 weeks and Arm 2 with 4 days every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- 5-Fluorouracil
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients randomized to Arm 1 will receive 5-FU as a 400mg/m2 bolus followed by 2,400 mg/m2 continuous intravenous infusion (CIVI) over a 46 hour time period every 2 weeks on Day 1-2 and Days 15-16. Each cycle is 28 days.
Patients randomized to Arm 2 will receive 5-FU as a 1000g/m2/day continuous intravenous infusion (CIVI) over 4 days every 3 weeks on Day 1-4. Each cycle is 21 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
The Joseph Sanchez Foundation
Collaborator
Citations
Fluorouracil sensitivity in a head and neck squamous cell ...
Altogether, the genomic findings point to the inability of the tumor to catabolize and deactivate 5-FU and therefore increase its therapeutic efficacy.
Oral 5-FU Alternatives for the Treatment of Head and Neck ...
[21] The overall response rate was 38% with a partial response rate of 19% and complete response rate of 19%. Additional trials have evaluated UFT in ...
Efficacy of concurrent cetuximab vs. 5-fluorouracil ...
On multivariate analysis, compared with cisplatin and 5FU/carboplatin, cetuximab was associated with inferior 4-year OS (86.9% vs. 70.2% vs. 40.9%; P < .0001) ...
Efficacy of concurrent cetuximab vs. 5-fluorouracil/carboplatin ...
Median LRFS was not reached. The 4-year LRF rate was 6.3% (95% CI, 3.3–9.4%) for cisplatin, 9.7% (95% CI, 1.5–17.9%) for 5FU/carboplatin, and 40.2% (95% CI, ...
Full article: Treatment efficacy of low-dose 5-fluorouracil ...
Low-dose 5-FU chemotherapy with 5-FU-MBs + US provides effective treatment for head and neck cancer. Figure 8 shows the tumor sizes estimated ...
A Patient's Guide to 5-Fluorouracil Side Effects
When you're starting on 5-fluorouracil, you'll likely hear about a few common side effects, like fatigue, nausea, diarrhea, and mouth sores.
Incidence of 5-fluorouracil related in cardiotoxicity in ...
However, 5-FU may induce acute cardiotoxicity preventing its subsequent use. Incidence of 5-FU-induced cardiotoxicity ranges from 0.99 to 19.9% ...
NCT03370406 | Intralesional 5-Fluorouracil (5FU), Topical ...
The goal of the study is to evaluate the safety profile and tolerability of intralesional-5FU with and without a concomitant topical calcipotriene and measure ...
day 5-Fluorouracil in Head and Neck Cancer Cells
The aim of this study was to investigate the anticancer effects of both regimens and underlying mechanisms in vitro. Materials and. Methods: Two head and neck ...
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