Chemo-embolization for Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT04595981 |
Recruitment Status :
Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : April 25, 2024
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Sponsor:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Jesse G. A. Jones, MD, University of Alabama at Birmingham
Tracking Information | |||||||
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First Submitted Date ICMJE | October 14, 2020 | ||||||
First Posted Date ICMJE | October 22, 2020 | ||||||
Last Update Posted Date | April 25, 2024 | ||||||
Estimated Study Start Date ICMJE | May 2025 | ||||||
Estimated Primary Completion Date | January 2028 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Evaluate progression free survival [ Time Frame: 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Chemo-embolization for Head and Neck Cancer | ||||||
Official Title ICMJE | Chemo-embolization for Head and Neck Cancer | ||||||
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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
Other Name: Platinol
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Study Arms ICMJE | Experimental: Chemo-embolization
Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)
Intervention: Drug: Cisplatin
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
48 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | January 2029 | ||||||
Estimated Primary Completion Date | January 2028 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04595981 | ||||||
Other Study ID Numbers ICMJE | IRB-300006231 UAB ( Other Identifier: UAB ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Jesse G. A. Jones, MD, University of Alabama at Birmingham | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Alabama at Birmingham | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |