Chemo-embolization for Head and Neck Cancer

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• 1. Provision of signed and dated informed consent form

• 2.Stated willingness to comply with all study procedures and availability for the duration of the study

• 3.Male or female, aged 18 or older

• 4.Diagnosed with squamous cell carcinoma of the Head and Neck

• 5.Ability to undergo chemo-embolization

• 6.For females of reproductive potential: Negative pregnancy test at time of chemo-embolization

• 7.Platinum-ineligible as determined by presence of CTS grade I nephropathy, neuropathy or otopathy, and/or ECOG 2+ performance status.

• 8.Plan to undergo standard of care radiation and chemo- and/or immunotherapy.

Exclusion Criteria:

• 1. Medically unfit to undergo chemo-embolization

• 2. Treatment with a competing investigational drug or intervention trial that does not allow adjuvant chemo-embolization.