Clinical trial NCT05600842: De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Official title: De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HPV-positive oropharyngeal cancer

Brief summary: This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.


Eligibility criteria: Inclusion Criteria:

* Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status.
* Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible;
* History/physical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss;
* Age ≥ 18;
* PET/CT within 6 weeks prior to registration;
* Patients must sign a study-specific informed consent form prior to study entry.
* Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.

Exclusion Criteria:

* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
* Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded;
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
* Receipt of prior radiotherapy that would result in overlap with proposed field.

Primary outcomes:
measure: 2-Year Progression-Free Survival
timeFrame: Given the natural history of this disease, PFS will be monitored up to 2 years from registration
Secondary outcomes:
measure: Overall survival
timeFrame: Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration
measure: Local-regional control
timeFrame: Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Eric Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: