This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.
This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck. Patients positive for p16 status will be approached for consent during the pre-treatment intake process. Contralateral neck progression will be measured by PET (positron emission tomography)/CT scans. Xerostomia will be measured by the EORTC QLQ (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) H\&N35 at 6, 12, and 24 months. Patients will remain on study treatment for 6-7 weeks or until unacceptable toxicity or withdrawal of consent. Disease free survival (DFS) and overall survival (OS) will be assessed until 24 months after completion of study treatment
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)
Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks )
Cisplatin, 40mg/m2 (weekly for 7 weeks)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGNumber of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment
To evaluate the development of cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment.
Time frame: 1 year
Level of xerostomia
To evaluate whether the omission of elective radiation to the contralateral neck decrease patient reported xerostomia at 6, 12, and 24 months to a mean score of 47.2 (from an expected 57.2) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35
Time frame: 2 years
Mean swallowing change (modified barium swallowing test)
To evaluate the functional swallowing change of patients treated with unilateral neck radiation as measured by a modified barium swallow for the period of one year after the end of radiotherapy. The investigators will use summary statistics such as changes in means and changes in proportions to evaluate the functional swallowing change of patients treated with unilateral neck radiation as measured by a modified barium swallow test.
Time frame: 2 years
Mean swallowing change (patient reported)
To evaluate patient reported swallowing of patients treated with unilateral neck radiation as measured by the EORTC QLQ H\&N 35 for the period of two years after the end of radiotherapy. The investigators will use summary statistics to characterize changes in means of reported swallowing for patients treated with unilateral neck radiation as measured by the EORTC QLQ H\&N 35. The investigators will use sign-rank tests to investigate if the changes are equal to zero.
Time frame: 2 years
Rate of contralateral neck progression
To evaluate the development of cancer on the contra-lateral side of the neck within 24 months of completion of radiation treatment. The investigators will use cumulative incidence curves and Fine and Gray proportional hazards regressions to characterize the rate of contralateral neck progression for the period of 2 years after the completion of radiation. In this analysis, death will be considered a competing risk.
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Time frame: 2 years
Overall survival (OS)
To evaluate the OS of head and neck cancer patients treated with unilateral neck radiation for the period of two years after the end of radiotherapy using Kaplan Meier curves and Cox proportional hazards regressions.
Time frame: 2 years
Disease free survival (DFS)
To evaluate the DFS in accordance with RECIST 1.1 of head and neck cancer patients treated with unilateral neck radiation for the period of two years after the end of radiotherapy using Kaplan Meier curves and Cox proportional hazards regressions.
Time frame: 2 years
Dosimetric degree of normal tissue avoidance
To quantify the dosimetric degree of normal tissue avoidance of unilateral neck radiation when compared to bilateral neck radiation using Wilcoxon Rank-Sum tests
Time frame: 2 years