Could less radiation be just as good for HPV throat cancer?
NCT ID NCT05491512
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing whether a much lower dose of radiation (30 Gy) combined with standard chemotherapy can control HPV-positive throat cancer as well as the usual high dose (70 Gy). The goal is to reduce side effects from radiation while still keeping the cancer from coming back. About 121 people with HPV-positive oropharyngeal cancer will take part.
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 (lower dose) combined with chemotherapy (cisplatin, carboplatin, 5-fluorouracil, paclitaxel, or abraxane)
- What this could lead to
- If successful, this could mean that people with HPV-positive throat cancer can get effective treatment with fewer long-term side effects from radiation.
- What could go wrong
- This is a Phase 2 trial with only 121 participants, so results are preliminary. Lower radiation might not control the cancer as well as the standard dose, and chemotherapy still carries risks like nausea, kidney problems, and nerve damage.
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 121 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Aug 2027
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: * Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from biopsy, surgical resection or excisional biopsy regardless of margin status. 1. Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI 2. Patient must have excisional biopsy or core biopsy done in order to be on protocol * Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations. * Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT. * CT or MRI of the neck with and without contrast Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools. * ECOG Performance Status of 0-2 or KPS ≥ 50 * Age ≥ 18 Patients over 70yrs will be able to enroll in Cohort B only). * Adequate hematologic function within 30 days prior to registration, defined as follows: 1. White Blood Count (WBC) ≥ 2 K/mcL 2. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 3. Platelets ≥ 100,000 cells/mm3 4. Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable * Adequate renal function within 30 days prior to registration, defined as follows: 1. Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male) Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical judgment will receive carboplatin and paclitaxel Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel). * Adequate hepatic function within 30 days prior to registration, defined as follows: 1. Bilirubin \< 2 mg/dl 2. AST or ALT \< 3 x the upper limit of normal Note: Exceptions can be made with PI and/or Co-Pi approval for patients to enroll on trial with a higher Bilirubin level such as Gilbert's Syndrome. Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical judgment will receive carboplatin and paclitaxel. Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel). * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential * The subject must provide study-specific informed consent prior to study entry * Subject able to undergo MRI scans except for major medical contraindications like presence of a pacemaker or approved by the PI or the CO-PI that the subject does not need to undergo MRI scans Exclusion Criteria: * Subjects with prior head and neck radiation therapy * Subjects with simultaneous primary cancers outside of the oropharynx a. Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI/Co-PI the patient can proceed with protocol activities. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable * Severe, active co-morbidity defined as follows: (exceptions can be made if approved by the PI and/or co-PI) 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 2. Transmural myocardial infarction within the last 6 months 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration 5. Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects
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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
7 sites. 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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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Cancer Center at Suffolk-Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can steroids, a migraine drug, or tongue exercises save nerves after throat cancer treatment?
- Can an HPV shot stop vulvar lesions from coming back?
- A gel that may help the cervix heal from HPV lesions faces a test
- Can heat make radiation more effective against head and neck cancer?
- MRI scans may reveal which throat cancer patients need stronger treatment
- Could a single HPV shot match the standard regimen?