| Eligibility |
Inclusion Criteria:
- Patients older than 18 years of age with histologically proven squamous cell carcinoma
of the oropharynx
- HPV-negative disease status by routine p16 immunohistochemical (IHC) staining or in
situ hybridization (ISH) of biopsied tumor tissue or >10 pack-year cigarette smoking
history
- Stage T1-4, N0-3 disease, as defined by American Joint Committee on Cancer (AJCC)
criteria
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) Performance Status 0-2.
Exclusion Criteria:
- Patients who have undergone resection of primary disease
- Patients who have received induction chemotherapy for their oropharynx cancer
diagnosis
- Prior cancer diagnosis within 5 years, except appropriately treated localized
epithelial skin cancer or cervical cancer
- Prior radiation therapy to the head and neck region
- Women of childbearing potential (a woman of child-bearing potential is a sexually
mature woman who has not undergone a hysterectomy or who has not been naturally
postmenopausal for at least 24 consecutive months [i.e., who has had menses at any
time in the preceding 24 months]) and male participants must practice effective
contraception (oral, injectable, or implantable hormonal contraceptive; tubal
ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized
partner) throughout the study
- Patient unable to tolerate MRI or having an estimated Glomerular Filtration Rate (GFR)
<60 ml/min/1.73 m2.
- 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 before
registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note,
however, that laboratory tests for liver function and coagulation parameters are not
required for entry into this protocol
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease
Control (CDC) definition; note, however, that HIV testing is not required for entry
into this protocol. The need to exclude patients with AIDS from this protocol is
necessary because the treatments involved in this protocol may be significantly
immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised
patients
- History or treatment with potent immunosuppressive drugs for such conditions as organ
transplant, severe rheumatoid arthritis, etc. within the past 6 months.
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