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Recruiting

NCT Number: NCT05600842

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Eric Chen, MD

CONTACT

[email protected]

877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensity-Modulated Radiation Therapy (IMRT)

Radiation

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 outcomes

  1. 2-Year Progression-Free Survival

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 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.

  2. Local-regional control

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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