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

ConditionHPV Positive Oropharyngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

Patients with HPV-positive oropharyngeal cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

111 Participants
are divided into 1 treatment group
Group A: De-escalated radiotherapy1 intervention

Trial outcomes

Primary outcomes

1

2-Year Progression-Free Survival

Progression-free survival (PFS) is defined as the time from registration to disease progression or death from any cause.

Time frame
Given the natural history of this disease, PFS will be monitored up to 2 years from registration

Secondary outcomes

1

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.

Time frame
Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration
2

Local-regional control

Local-regional control is defined as the absence of local and/or regional progression.

Time frame
Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov
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