NCT04595981

Chemo-embolization for Head and Neck Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SCCHN
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Subjects will be admitted to the UAB Heart and Vascular Center, pre-medicated with 24 mg Ondansetron IV, 500 mg Prednisolone IV and 1.5 L NaCl with 20 meq KCl IV. The chemo-embolic agent is prepared in the HVC pharmacy by reconstituting 300 mg lyophilized Cisplatin in 60 mL 0.9% NaCl. Subjects are placed under anesthesia in the angiography suite. The access site is prepped and draped in sterile fashion then the femoral artery is catheterized using a 5-French catheter containing a coaxial microcatheter. After superselective visualization of the tumor-feeding vessel, a microcatheter is advanced into the target vessel and infused with 150 mg m2 cisplatin in 45-60 mL NaCl over 30-60 seconds. 10 seconds after the infusion starts, 9 gm sodium thiosulphate is administered IV to neutralize systemic Cisplatin. A post-infusion angiogram is then performed to assess the adequacy of embolization. The catheter is removed and the arteriotomy site closed with a subcutaneous suture.

Timeline

• Start date: 2027-05-01
• Primary completion: 2029-05-01
• Completion: 2030-05-01
• First posted: 2020-10-22
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study