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Chemo-Emboli zation for Head and Neck Cancer

JJ
Overseen ByJesse Jones, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Alabama at Birmingham
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

Who Is on the Research Team?

JJ

Jesse Jones, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 with squamous cell carcinoma of the head and neck who can't use cisplatin due to certain health issues like kidney, nerve, or ear problems. They must be able to have chemo-embolization, follow study rules, and plan standard cancer treatments. Pregnant women and those unfit for the procedure are excluded.

Inclusion Criteria

I have been diagnosed with squamous cell carcinoma in my head or neck.
I cannot receive platinum-based chemotherapy due to kidney, nerve, or ear problems, or because my physical health status is limited.
I am planning to receive standard radiation and either chemotherapy or immunotherapy.
See 4 more

Exclusion Criteria

You are already participating in a clinical trial that doesn't allow adjuvant chemo-embolization or taking another investigational drug.
I cannot undergo chemo-embolization due to my health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant chemo-embolization in addition to standard of care radiation and chemo- and/or immunotherapy

6 months
Monthly visits for treatment and monitoring

Follow-up

Participants are monitored for progression free survival and overall survival

2 years
Regular imaging and oncology team assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Cisplatin
Trial Overview The study tests if adding chemo-embolization to usual cancer care (radiation plus chemotherapy/immunotherapy) helps patients live longer without their cancer getting worse compared to just standard care in those who cannot tolerate cisplatin.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Chemo-embolizationExperimental Treatment1 Intervention

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Platinol for:
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Approved in United States as Platinol for:
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Approved in Canada as Platinol for:
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Approved in Japan as Platinol for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+
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