A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)

Exclusion Criteria

• •cT4, cN3, or cM1 disease (also explained as AJCC 8th edition clinical staging,)
• •Patients with radiographic ECE or matted lymph nodes, defined as three nodes abutting one another with loss of intervening fat plane that is a replaced with radiologic evidence of extracapsular spread.
• •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
• •Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \>3 years prior to study;
• •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
• •Prior allergic reaction or hypersensitivity reactions to paclitaxel, carboplatin or other platinum containing products. This also includes patients with a history of severe hypersensitivity reaction to products containing Cremophor EL.
• •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 3 months;
• •* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• •* Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
• •* Acquired Immune Deficiency Syndrome (AIDS) based upon current 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.
• •* 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.
• •* Severe bone marrow depression or significant bleeding
• •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.
• •For Cohort B, poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) despite 2 attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians.
• •Active enrollment on another clinical trial involving active treatment for the study cancer.