In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. While the long-term consequences of chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients. Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good prognosis features will then be followed without postoperative radiotherapy. Patients with subsequent recurrence will be treated with either surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is expected that over 50% of patients treated with surgery will have had a curative treatment and will avoid radiation therapy entirely and long-term survival will not be changed by withholding radiation therapy to good prognosis patients after surgery. There are exploratory biomarkers of risk of recurrence that will be collected and studied. There are currently few trials examining the role of de-escalation using surgery alone in intermediate and early T-stage HPV related disease. New surgical techniques have broadened the range of patients capable of achieving a complete resection and the functional outcomes in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and radiotherapy raise the possibility that delayed or salvage treatment in early stage patients would be highly effective, would result in similar survival outcomes and radiotherapy could be applied to a much smaller population then current standards call for. Looked at from a different perspective, the need for post-operative radiotherapy in this younger, HPV+ and more functional population has not been validated in clinical trials to date.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
PET scan or CT scan q 4 months for 5 years
Postoperative XRT 5000 cGy
CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 5000 cGy
CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 5600 cGy
Mount Sinai Beth Israel
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Disease Specific Survival (DSS)
Number of participants with HPV related oropharynx cancer treated with a de-intensified adjuvant protocol with status of disease specific survival. DSS was calculated by measuring the time from trial entry to cancer-related death.
Time frame: 5 years
Number of Participants With Progression-Free Survival (PFS)
Number of participants with HPV related oropharynx cancer treated with a de-intensified adjuvant protocol with status of progression-free survival. PFS calculated the time to biopsy confirmed recurrence or death from any cause.
Time frame: 5 years
Number of Participants With Locoregional Failures (LRFs)
the rate of local regional control (LRC) in patients with early and intermediate stage HPV related oropharynx cancer treated with surgery alone as assessed by number of participants with locoregional failures.
Time frame: 5 years
Overall Survival
Overall survival (OS) in patients with early and intermediate stage HPV related oropharynx cancer treated with surgery alone. OS from the time of entry to death with any cause.
Time frame: 5 years
Number of Serious Adverse Events
Number of serious adverse events
Time frame: 5 years
Global Quality of Life Scores
Global Quality of Life Scores total score from 0-100, with higher score indicating better health outcomes.
Time frame: 2 years
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