Chemo-embolization for Head and Neck Cancer

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04595981

Patient View

This Phase II trial at UAB explores chemo-embolization's impact on progression-free and overall survival in cisplatin-ineligible head and neck cancer patients. Eligibility includes adults with squamous cell carcinoma, unable to receive cisplatin, and planning standard care. The intervention involves cisplatin infusion via catheter, followed by sodium thiosulphate to neutralize systemic effects.

Patient Parameters

Program Overview

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.

Description

This is a single site, single arm Phase II trial pilot study to explore if chemo-embolization increases progression free and/or overall survival in a subpopulation of cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate in the U.S. Chemo-embolization will serve as adjuvant therapy performed in addition to standard of care radiation and chemo- and/or immunotherapy. Within UAB, the Investigators plan to recruit 48 patients to implement the intervention, within a two-year period. Progression free survival will be assessed at 3, 6 and 24 months (if available) after intervention, which is determined based upon the results of follow-up Head and Neck imaging (CT or MRI) interpreted by a Radiologist not involved in the study, per standard of care. Overall survival will be reported by the patients' Oncology team on a monthly basis. The trial endpoints will form the basis of how PFS and OS compare to historical outcomes in a similar cohort of patients.

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

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