Status:
COMPLETED
PET-MRI Assessment of Early Tumor Response to Predict Outcomes of HPV-Positive Oropharynx Cancer Patients
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Squamous Cell Carcinoma
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This proposal explores the novel hypothesis that the variability in outcomes within the Intermediate Risk(IR) HPV-positive Oropharynx Squamous Cell Carcinoma(OPSCC) cohort can be exploited to identify...
Eligibility Criteria
Inclusion
- Histologically- or cytologically-proven diagnosis of squamous cell carcinoma (including papillary squamous cell carcinoma and basaloid squamous cell carcinoma variants) of the oropharynx (tonsil or base of tongue)
- III-IVB (T3N0, T1-3N1, T4aN0-3, T4bN0-3, T1-4N2, T1-4N3) (AJCC 8th edition) based upon the following minimum diagnostic workup:
- General history and physical examination (including nasolarygopharyngoscopy or indirect mirror exam) by a radiation oncologist or medical oncologist or ENT head and neck surgeon within 8 weeks prior to registration.
- Diagnostic CT of the neck with IV contrast
- Chest imaging
- CXR or CT chest without contrast
- Patient must not have any contraindications to undergoing a 3.0T PET-MRI
- Zubrod Performance Status 0-1 within 2 weeks prior to registration.
- Smoking history defined by pack-years (calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked).
- Negative urine pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- Patient must provide study specific informed consent prior to study entry.
Exclusion
- Cancers considered to be from an oral cavity, nasopharynx, hypopharynx, or larynx are excluded. Carcinoma of the neck of unknown primary site origin (even if p16 positive) are excluded.
- Distant metastasis
- Gross total excision of the primary tumor with or without nodal dissection.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma of the breast, colon or cervix are all permissible if patients are disease free for ≥ 3 years.)
- Prior radiotherapy to the head and neck region that would result in overlap of radiation therapy fields.
- Presence of passive and/or active devices that are not compatible with the 3.0T PET/MR scanner environment. Any person with the following will be excluded: cardiac pacemaker, metal fragments in or around the eye, venous umbrella, permanent eyeliner or permanent artificial eyebrows. Patents with the following potentially non-MRI compatible devices will undergo screening using the standard UWHC MRI screening protocol by trained UWHC personnel: cardiac pacemaker, heart valve replacement, intracranial aneurysm clips, middle ear, eye, joint, or penile implants, joint replacements, implantable hearing aids, neurostimulator devices, insulin pumps, shunts/stents, metal mesh/coil implants; metal plate/pin/screws/wires, or any other metallic implants. Also, patients with anatomical constraints limiting the feasibility of MRI will be excluded.
Key Trial Info
Start Date :
May 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 15 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03342378
Start Date
May 3 2018
End Date
May 15 2021
Last Update
November 21 2022
Active Locations (1)
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1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792