Could less be more? trial tests reduced radiation and chemo after surgery for HPV-Linked throat cancer

NCT ID NCT05388773

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This trial studies people with HPV-positive oropharynx cancer whose tumors can be surgically removed. After surgery, patients are grouped by risk: low-risk patients get no further treatment, intermediate-risk get a lower dose of radiation, and high-risk get lower-dose radiation plus chemotherapy. The goal is to see if this tailored, less-intense approach can keep the cancer from coming back while reducing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transoral surgery followed by risk-based de-escalated intensity-modulated radiation therapy (IMRT) with or without cisplatin or carboplatin chemotherapy
What this could lead to
If successful, this approach could show that many patients with HPV-positive throat cancer can receive less aggressive radiation and chemotherapy after surgery without compromising cancer control, reducing long-term side effects.
What could go wrong
This is a mid-stage trial with 150 participants, so results may not apply to all patients. De-escalated therapy could lead to higher recurrence rates in some risk groups.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ECOG performance status of 0 or 1 or Karnofsky score 80-100. * Preference is to register patients prior to surgery. However, if not registered prior to surgery, the patient can be registered prior to adjuvant therapy. * Patients must have newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx. Patients must have been determined to have resectable oropharyngeal disease. Patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible. * Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies. Metastatic disease may be evaluated using CT or PET/CT where appropriate; this can be performed with or without contrast. The following imaging is acceptable to evaluate the primary and regional disease: * CT Neck (with contrast preferred but not required) * PET/CT * MRI Neck (contrast preferred but not required) * Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node. * Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory. Using p16 antibody obtained from Roche mtm laboratories AG (CINtec, clone E6H4) is recommended. * No prior radiation above the clavicles. * Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non- melanomatous skin cancer. * Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist prior to entry into the study. * Congestive heart failure \> NYHA Class II * CVA/TIA * Unstable angina * Myocardial infarction (with or without ST elevation) * Patients must have acceptable renal and hepatic function within 4 weeks prior to registration o For patients stratified following surgery and to concurrent chemotherapy (Arm CRT), calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula * In patients with a contraindication to cisplatin, carboplatin can be used at time of patient enrollment if they are allocated to ARM CRT. Exclusion Criteria: * No evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging. * Patients must not need a microvascular (free flap) reconstruction. Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * Patient must not have an intercurrent illness likely to interfere with protocol therapy or prevent surgical resection * Patients must not have uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled hypertension within 30 days prior to registration.

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Conditions

The condition(s) this trial relates to.

DNA Virus Infections epithelial neoplasm Head and Neck Neoplasms human papilloma virus infection oropharynx cancer oropharynx squamous cell carcinoma otorhinolaryngologic disease Otorhinolaryngologic Neoplasms papilloma Pharyngeal Diseases pharynx cancer squamous cell carcinoma Stomatognathic Diseases Tumor Virus Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

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