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Trial Title:
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
NCT ID:
NCT05600842
Condition:
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity-Modulated Radiation Therapy (IMRT)
Description:
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.
Arm group label:
De-escalated radiotherapy
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.
Criteria for eligibility:
Study pop:
Patients with HPV-positive oropharyngeal cancer
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chao Family Comprehensive Cancer Center, University of California, Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allen M Chen, MD
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Start date:
November 3, 2022
Completion date:
November 2026
Lead sponsor:
Agency:
University of California, Irvine
Agency class:
Other
Source:
University of California, Irvine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600842
