PET-MRI Assessment of Early Tumor Response to Predict Outcomes of HPV-Positive Oropharynx Cancer Patients

Inclusion Criteria:

- 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.

- Required labs:

- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3.

- Platelets ≥ 100,000 cells/mm3.

- Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to
achieve Hgb ≥ 8.0 g/dl is acceptable, but not within 2 weeks of start of
treatment.

- Bilirubin ≤ 2 mg/dl within 2 weeks prior to registration.

- AST or ALT ≤ 3 x the upper limit of normal within 2 weeks prior to registration.

- Serum creatinine ≤ 1.5 mg/dl within 2 weeks prior to registration or creatinine
clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by
24-hour collection or estimated by Cockcroft-Gault formula:

- CCr male = [(140 - age) x (weight in kg)]/[(Serum Cr mg/dl) x (72)]

- CCr female = 0.85 x (CCr male)

- Patient must be deemed able to receive weekly cisplatin chemotherapy

- 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 serum 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 Criteria:

- Cancers considered to be from an oral cavity, nasopharynx, hypopharynx, larynx, and
oropharynx primaries confined entire to the soft palate and posterior oropharyngeal
wall even if p16 positive, are excluded. Carcinoma of the neck of unknown primary site
origin (even if p16 positive) are excluded. Patients with a primary tumor not able to
be defined by PET-MRI are excluded.

- Distant metastasis or adenopathy below the clavicles.

- 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.

- Severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months.

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration.

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days of
registration.

- Pregnancy or women of childbearing potential and men who are sexually active and
not willing/able to use medically acceptable forms of contraception; this
exclusion is necessary because the treatment involved in this study may be
significantly teratogenic.

- Patients who are unfit for cisplatin chemotherapy due to concomitant conditions,
including but not limited to significant peripheral neuropathy, worsening renal
function, hearing loss, or other toxicities that prevents treatment with
cisplatin chemotherapy.

- 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.