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Chemo-embolization for Head and Neck Cancer

Primary Purpose

SCCHN, Squamous Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SCCHN focused on measuring Chemo-embolization, Chemoembolization, Squamous Cell Carcinoma of Head and Neck, SCCHN, Platinum-ineligible

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo-embolization

Arm Description

Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)

Outcomes

Primary Outcome Measures

Evaluate progression free survival
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

Evaluate overall survival
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
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.

Full Information

First Posted
October 14, 2020
Last Updated
August 9, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04595981
Brief Title
Chemo-embolization for Head and Neck Cancer
Official Title
Chemo-embolization for Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SCCHN, Squamous Cell Carcinoma
Keywords
Chemo-embolization, Chemoembolization, Squamous Cell Carcinoma of Head and Neck, SCCHN, Platinum-ineligible

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemo-embolization
Arm Type
Experimental
Arm Description
Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate progression free survival
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Evaluate overall survival
Description
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.
Time Frame
2 Years
Title
Evaluate oropharyngeal bleeding
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Jones, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chemo-embolization for Head and Neck Cancer

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