Recruiting NCT05600842
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensity-Modulated Radiation Therapy (IMRT).
- Who it may be relevant to
- Registry conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Radiation Intensity-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.
Primary outcome measures
- 2-Year Progression-Free Survival [Time frame: Given the natural history of this disease, PFS will be monitored up to 2 years from registration]
Secondary outcome measures (2)
- Overall survival [Time frame: Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration]
- Local-regional control [Time frame: Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange
Identifiers
NCT: NCT05600842 · 2048 · UCI 22-132