Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT02258659
Eligibility Criteria:
Inclusion Criteria:
* Patients must have pathologically confirmed HPV-positive squamous cell carcinoma
* HPV testing must follow the following criteria
* HPV testing using an E6/E7 based assay is preferred, and does not require any validation (e.g. HPV in situ hybridization \[ISH\] or HPV E6/E7 polymerase chain reaction \[PCR\])
* For oropharyngeal tumors p16 immunohistochemistry (IHC) positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan/Lingen et al 2012); it is recommended that p16 IHC positivity is validated at a later point (during or after treatment) using an E6/E7 based test at the University of Chicago and provided slides will be used
* For non-operative (OP) tumors accurate HPV testing (i.e. ISH, or E6/E7 based testing) is required for enrollment and treatment initiation
* Availability of \>= 10 unstained 5 micron slides
* Patients with American Joint Committee on Cancer (AJCC) (7th edition, 2010) nodal stage N2 or N3 or a T4 primary tumor
* The primary and nodal involvement must be assessable on clinical exam (mucosal and lymph node exam)
* The primary and nodal involvement must have been defined bi- or uni-dimensional measurements measurable by RECIST
* No previous radiation or chemotherapy for a head and neck cancer
* No surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy of the tumor is acceptable)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky \>= 70%)
* Leukocytes \>= 3000/mm\^3
* Platelets \>= 100,000/mm\^3
* Absolute neutrophil count \>= 1,500
* Hemoglobin \> 9.0 gm/dL
* Albumin \> 2.9 gm/dL
* Total bilirubin =\< 1.5 mg/dl
* Creatinine clearance \> 45 mL/min (or serum creatinine \[SCr\] =\< 1.5 mg/dL), normal within 2 weeks prior to start of treatment
* The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate creatinine clearance (CrCl) for enrollment or dosing
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 X upper limit of normal (ULN)
* Alkaline phosphatase =\< 2.5 X ULN
* Patients must sign a study-specific informed consent form prior to study entry; patients should have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Unequivocal demonstration of distant metastases (M1 disease)
* Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival; including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance
* Pregnant and nursing women are excluded; men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy; women with child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening
* Other coexisting malignancies or malignancies diagnosed within the previous 3 years no evidence of disease for at least 3 years; exceptions to this include non-melanoma skin cancer, cervical cancer in situ, well differentiated thyroid cancer or prostate cancer; other cancers that per assessment of the PI are not prognosis limiting can be allowed after review by the PI
* Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor; residual tumor is required for enrollment on study
* Patients receiving other investigational agents
* Peripheral neuropathy \>= grade 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02258659
Study Brief:
Protocol Section:
NCT02258659