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Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to registration; specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site
• For patients with oropharyngeal cancer (OPC)/cancer of unknown
primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification.
* Note: Institutions must screen patients for p16 status by
immunohistochemistry (IHC) in order to be eligible for the trial
using a Clinical Laboratory Improvement Amendments (CLIA)-
certified laboratory. A rigorous laboratory accreditation process
similar to the United States (U.S.) CLIA certification, such as the
provincial accreditation status offered by the Ontario Laboratory
Accreditation (OLA) Program in Canada, the College of American
Pathologists (CAP), or an equivalent accreditation in other
countries, is acceptable.
• The p16 results must be reported on the pathology report
being submitted. The p16 positivity is defined as > 70% of
tumor cells showing strong nuclear and/or cytoplasmic
immunostaining with p16 antibody.
• For patients with laryngeal and hypopharyngeal primaries:
Analysis of p16 status is NOT required.
• Patients must have clinically or radiographically evident
measurable disease at the primary site or at nodal
stations. Simple tonsillectomy or local excision of the
primary without removal of nodal disease is permitted, as
is excision removing gross nodal disease but with intact
primary site. Limited neck dissections retrieving =< 4
nodes are permitted and considered as non-therapeutic
nodal excisions
• Clinical stage (American Joint Committee on Cancer
[AJCC], 8th ed.), including no distant metastases based
on the following diagnostic workup:
• History/physical examination within 60 days prior to
registration
• One of the following imaging studies is required within 60
days prior to registration:
• Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless contraindicated) OR
• Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless contraindicated) OR
• Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT component must be of diagnostic quality with contrast, unless contraindicated.
* Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT
scan of neck performed for the purposes of radiation planning may
serve as both staging and planning tools
• One of the following imaging studies is required within 60
days prior to registration:
• FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR
• Chest CT
• Exam with laryngopharyngoscopy (mirror or in office direct
procedure acceptable) within 70 days prior to registration
• Eligibility by patient cohort;
• Non-OPC/p16-negative OPC Cohort; Tumor Site:
Larynx/Hypopharynx; Clinical Staging (AJCC, 8th ed.): T3-4 N0 or
T1-4 N1-3 T2 N0 (hypopharynx only)
• Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.):
T2N1, T1-4 N2-3, or T3-4 N0-1
• p16-positive OPC/CUP Cohort;
• Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical
Staging (AJCC, 8th ed.): T1-3 N2-3 or T4 N0-3
• Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical
Staging (AJCC, 8th ed.): T1N2-3, T2N1-3, or T3-4 N0-3
• Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC,
8th ed.): T0 N2-3 Note: Cigar and pipe tobacco consumption is not
included in calculating the lifetime pack-years. Marijuana
consumption is likewise not considered in this calculation. There is
also no clear scientific evidence regarding the role of chewing
tobacco-containing products in oropharyngeal cancer, although this
is possibly more concerning given the proximity of the oral cavity
and oropharynx. In any case, investigators should not count use of
non-cigarette tobacco products in the pack-years calculation.
• Age >= 18
• Zubrod (Eastern Cooperative Oncology Group [ECOG])
performance status of 0-1 within 14 days prior to registration
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within
30 days prior to registration)
• Platelets >= 75,000 cells/mm^3 (within 30 days prior to
registration)
• Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
* Note: The use of transfusion or other intervention to
achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
• Calculated creatinine clearance (CrCl) >= 50 mL/min by the
Cockcroft-Gault formula (within 30 days prior to registration)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
(within 30 days prior to registration) (not applicable to patients
with known Gilbert's syndrome)
• Aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) =< 1.5 x institutional ULN (within 30
days prior to registration)
• Known human immunodeficiency virus (HIV) infected patients
on effective anti-retroviral therapy with undetectable viral load
within 6 months and CD4 T Cell count > 200 cells/mm^3 are
eligible for this trial. Testing is not required for entry into
protocol
• Patients with a prior or concurrent malignancy whose natural
history or treatment does not have the potential to interfere
with the safety or efficacy assessment of the investigational
regimen are eligible for this trial
• Negative urine or serum pregnancy test (in persons of
childbearing potential) within 14 days prior to registration.
Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical
sterilization (hysterectomy or bilateral oophorectomy) or who
is not postmenopausal. Menopause is defined clinically as 12
months of amenorrhea in a woman over 45 in the absence of
other biological or physiological causes
• Willing to use highly effective contraceptives for participants
of childbearing potential (participants who may become
pregnant or who may impregnate a partner) during therapy
and for 14 months (females); for 11 months (males) following
last dose of cisplatin; this inclusion is necessary because the
treatment in this study may be significantly teratogenic.
• The patient or a legally authorized representative must
provide study-specific informed consent prior to study entry
and, for patients treated in the United States (U.S.),
authorization permitting release of personal health information
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