Could less radiation be enough for HPV throat cancer?
NCT ID NCT06984861
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether giving lower doses of radiation over a shorter time, along with standard chemotherapy, works as well as the usual higher radiation doses for people with HPV-positive throat cancer. About 74 participants will receive chemoradiation with drugs like cisplatin or carboplatin. The goal is to see if the cancer stays under control for at least two years, while possibly reducing side effects from radiation.
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)
- What this could lead to
- If successful, this could lead to a treatment option that uses less radiation for HPV-positive throat cancer, potentially reducing long-term side effects while maintaining effectiveness.
- What could go wrong
- This is a Phase 2 trial with only 74 participants, so results are preliminary. Lower radiation might not control the cancer as well as standard doses, and chemotherapy side effects remain a risk.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
May 2028
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 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. Patient must have excisional biopsy or core biopsy done in order to be on protocol. Note: Evidence of HPV associated oropharyngeal cancer from either the primary tumor site or from a lymph node. A patient is HPV positive when he or she tests positive having tested positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization. * Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations. * T3-4/N0-2c or any N3 regardless of Tstage (AJCC 7th Edition) HPV+ OPC\* or HPV associated squamous cell carcinoma with nodal metastasis (es) but unknown primary sites without evidence of distant metastasis based on FDG PET/CT. * CT Neck with contrast 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 ≥ 70 * Age ≥ 18 * 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/mm\^3 3. Platelets ≥ 100,000 cells/mm\^3 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: a. 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 * 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: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical judgment will receive carboplatin and paclitaxel. Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential * One cycle of induction chemo therapy is allowed prior to registration based on clinical needs. * 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 if determined by the PI/Co-PI the patient can proceed with protocol activities. 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HPV-associated oropharyngeal squamous cell carcinoma are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
7 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
-
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
-
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 heat make radiation more effective against head and neck cancer?
- Blood test may tailor throat cancer treatment, sparing patients from harsh side effects
- Can heat boost chemo? early trial tests thermotherapy for head and neck cancer
- Could a common numbing drug help fight throat cancer?
- Throat cancer diagnosis could get faster and more accurate with new ultrasound technique
- Stanford launches massive study to track oropharyngeal cancer over time