HPV Positive Oropharyngeal Squamous Cell Carcinoma
Conditions
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.
Interventions
RADIATIONIntensity-Modulated Radiation Therapy (IMRT)
IMRT will be given in 30 daily fractions at 2 Gy per fraction (60 Gy total) beginning Day 1; Six fractions will be delivered per week. High risk patients will receive induction chemotherapy with 2 cycles of carboplatin and paclitaxel.
Sponsors
University of California, Irvine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-Year Progression-Free Survival | Given the natural history of this disease, PFS will be monitored up to 2 years from registration | Progression-free survival (PFS) is defined as the time from registration to disease progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration | Survival time will be measured from the date of randomization to the date of death due to any cause or last follow-up. |
| Local-regional control | Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration | Local-regional control is defined as the absence of local and/or regional progression. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Chen, MD
Chao Family Comprehensive Cancer Center
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
Outcome results
None listed