Chemo-embolization for Head and Neck Cancer

Phase 2

Not yet recruiting

• Conditions: SCCHN; Squamous Cell Carcinoma
• Interventions: Drug: Cisplatin

• Registration Number: NCT04595981
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Study Start: 2025-05
• Primary Completion: 2028-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemo-embolization	Cisplatin	Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)

Primary Outcome Measures

Name	Time	Method
Evaluate progression free survival	6 Months	Progression free survival is the length of time from the day of the chemo-embolization procedure that a patient lives with the disease but it does not get worse. Cumulative progression-free survival for all patients will be calculated by the Kaplan-Meier method, including the point estimates of progression-free survival and the 95% confidence intervals, evaluated during a six-month period of follow-up.

Secondary Outcome Measures

Name	Time	Method
Evaluate overall survival	2 Years	Although the overall survival is related to the primary endpoint (progression free survival), it will be measured independent of the progression free survival. Overall survival is defined for all patients and measured from time of treatment to death or end of a study.
Evaluate oropharyngeal bleeding	2 years	Physician visits prompted by new oropharyngeal bleeding that occurs after chemo-embolization will be tabulated. Cumulative bleed-free survival for all patients will be calculated by the Kaplan-Meier method, including the point estimates of bleed-free survival and the 95% confidence intervals, evaluated during a six-month period of follow-up.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States