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squamous cell carcinoma
follicle stimulating hormone
head and neck cancer
fine needle aspiration
intensity-modulated radiation therapy
hepatitis b virus surface antigen
hepatitis c virus ribonucleic acid
This phase II/III trial studies how well a reduced dose of radiation therapy works with
nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive
oropharyngeal cancer that is early in its growth and may not have spread to other parts of
the body (early-stage), and is not associated with smoking. Radiation therapy uses
high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as
cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with
monoclonal antibodies, such as nivolumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is
being done to see if a reduced dose of radiation therapy and nivolumab works as well as
standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.
I. To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent
reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation
therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin).
(Phase II) II. To demonstrate co-primary endpoints of non-inferiority of PFS and superiority
of quality of life (QOL) as measured by the MD Anderson Dysphagia Inventory (MDADI) of
concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with
nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase III)
I. To compare patterns of failure (local and regional relapse versus distant) and overall
survival between each experimental arm and the control arm.
II. To assess long term PFS, overall survival, and toxicity between each experimental arm and
the control arm.
III. To determine acute and late toxicity profiles as measured by the Common Terminology
Criteria for Adverse Events (CTCAE).
IV. To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as
measured by the Patient-Reported Outcomes (PRO)-CTCAE.
V. To compare changes in patient-reported outcomes (Hearing Handicap Inventory for
Adults-Screening [HHIA-S], European Organization for Research and Treatment of Cancer
[EORTC]-Quality of Life Questionnaire [QLQ]30) between each experimental arm and the control
VI. To assess the association of fludeoxyglucose F-18 (FDG)-positron emission tomography
(PET)/computed tomography (CT) at baseline with locoregional control and PFS.
VII. To estimate the negative predictive value of the 12-14 weeks post-radiation therapy (RT)
FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.
I. To collect blood and tissue specimens for future translation research. II. To optimize
radiotherapy treatment plan quality assurance methodology for radiotherapy planning and
III. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension
Five Level Scale [EQ-5D-5L]) between each experimental arm and the control arm.
IV. To collect Modified Barium Swallow (MBS) data for future review and analysis.
PHASE II: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo intensity modulated radiation therapy (IMRT) or image-guided
radiation therapy (IGRT) over 6 fractions per week and receive cisplatin intravenously (IV)
over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of
disease progression or unacceptable toxicity.
ARM II: Patients undergo reduced dose IMRT or IGRT once daily (QD) over 5 fractions per week
and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks
in the absence of disease progression or unacceptable toxicity.
ARM III: Beginning 1 week prior to radiation, patients receive nivolumab IV over 30 minutes
on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of
disease progression or unacceptable toxicity. Patients also undergo reduced dose IMRT or IGRT
over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable
PHASE III: Patients are randomized to Arm I, Arm II, and/or Arm III.
After completion of study treatment, patients are followed up at 12-14 weeks, every 3 months
for 2 years, every 6 months for 3 years, and then annually thereafter.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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