Could less be more? trial tests reduced radiation and chemo after surgery for HPV-Linked throat cancer
NCT ID NCT05388773
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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- Can a more intense radiation schedule outperform Chemo-Radiation for head and neck cancer?
- Can less radiation be safer for throat cancer?
- Could a PET scan spare throat cancer patients from High-Dose radiation?
- Can light be the new shield against radiation mouth sores?