Clinical trial NCT04595981: Chemo-embolization for Head and Neck Cancer
Official title: Chemo-embolization for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: SCCHN
Squamous Cell Carcinoma
Keywords: Chemo-embolization
Chemoembolization
Squamous Cell Carcinoma of Head and Neck
SCCHN
Platinum-ineligible
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Evaluate progression free survival
timeFrame: 6 Months
Secondary outcomes:
measure: Evaluate overall survival
timeFrame: 2 Years
measure: Evaluate oropharyngeal bleeding
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Jesse Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: