Could a PET scan spare throat cancer patients from High-Dose radiation?
NCT ID NCT03416153
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial tests a personalized approach to radiation therapy for people with HPV-related oropharynx cancer. Doctors use PET-CT scans taken before and during treatment to see how well the tumor is responding. If the response is good, the radiation dose is reduced, which may lessen side effects like difficulty swallowing and dry mouth. The study aims to see if this de-escalated approach can still control the cancer effectively while improving quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy with dose adjustment guided by PET-CT scans, combined with chemotherapy (carboplatin and paclitaxel)
- What this could lead to
- If successful, this approach could allow some patients with HPV-related throat cancer to receive lower radiation doses, potentially reducing side effects while maintaining high cure rates.
- What could go wrong
- This is a phase II trial with a relatively small number of participants. The main risk is that reducing radiation might increase the chance of cancer recurrence, and the study is designed to monitor this carefully.
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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91 people
The number who actually took part.
- Started
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May 2018
- Finished
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May 2025
- 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: * Patients must have FDG-avid and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization. * AJCC eighth edition staging stage 1 and stage 2 * Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: * History/physical examination, including documentation of weight within 4 weeks prior to registration; * FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration; * Zubrod Performance Status (A quantification of the functional status of cancer patients that runs from 0 to 5, with 0 denoting perfect health and 5 death) 0-1 within 4 weeks prior to registration; * Age ≥ 18; * Able to tolerate PET/CT imaging required to be performed * CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function; * Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml/min within 4 weeks prior to registration; * Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study. * The patient must provide study-specific informed consent prior to study entry. Exclusion Criteria: * cT4, cN3 or cM1 disease * "Matted nodes" as determined by review with Neuroradiology * Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed. * Carcinoma of the neck of unknown primary site origin (even if p16 positive); * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \> 3 years prior to study; * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; * Severe, active co-morbidity; * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; * Poorly controlled diabetes
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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.
Contacts and locations
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
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VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a shorter, targeted radiation course tame throat cancer?
- MRI-Guided tweaks during radiation could spare throat cancer patients from swallowing woes
- Can a more intense radiation schedule outperform Chemo-Radiation for head and neck cancer?
- Can less radiation be safer for throat cancer?
- Could less be more? trial tests reduced radiation and chemo after surgery for HPV-Linked throat cancer
- Can light be the new shield against radiation mouth sores?