De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

HPV Positive Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:

De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600842
• Other study ID #: 2048
• Secondary ID: UCI 22-132
• Status: Recruiting
• Start date: November 3, 2022
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 877-827-8839
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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.

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center, University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-Year Progression-Free Survival	Progression-free survival (PFS) is defined as the time from registration to disease progression or death from any cause.	Given the natural history of this disease, PFS will be monitored up to 2 years from registration
Secondary	Overall survival	Survival time will be measured from the date of randomization to the date of death due to any cause or last follow-up.	Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration
Secondary	Local-regional control	Local-regional control is defined as the absence of local and/or regional progression.	Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration