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I'm interested ...!!
Chemo-embolization for Head and Neck Cancer
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.
Conditions:
🦠 SCCHN 🦠 Squamous Cell Carcinoma
🗓️ Study Start (Actual) May 2025
🗓️ Primary Completion (Estimated) January 2028
✅ Study Completion (Estimated) January 2029
👥 Enrollment (Estimated) 48
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 14 October 2020
  • First Submitted that Met QC Criteria 19 October 2020
  • First Posted 22 October 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 April 2024
  • Last Update Posted 25 April 2024
  • Last Verified April 2024
I'm interested ...!!