Could less radiation be enough for head and neck cancer?
NCT ID NCT05544136
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests whether giving lower doses of radiation to certain head and neck cancer patients can still effectively treat the cancer while causing fewer side effects. Participants receive chemotherapy and radiation, and doctors use a special PET scan to decide who can get the lower dose. The study is small, with only 12 people, and aims to see if this approach is worth testing in larger trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carboplatin chemotherapy and radiation therapy
- What this could lead to
- If successful, this could show that some patients with head and neck cancer can safely receive lower radiation doses, reducing long-term side effects.
- What could go wrong
- This is a very small pilot study with only 12 participants, so results may not apply to everyone. The lower radiation might not control the cancer as well as standard treatment.
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 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Mar 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: * Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity/paranasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies). * Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and/or co-PI approval) * If the primary site is oropharynx or unknown primary, P16 IHC must be negative. * If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible. * Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET/CT. * 18 years of age or older. * Must not have received prior radiation therapy or chemotherapy for HNC. * Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study. * Karnofsky Performance Status (KPS) ≥ 70. * CT or MRI of the Neck with and without contrast o Note: A CT scan of the Neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools. * Adequate hematologic function within 30 days prior to registration, defined as follows: * White Blood Count (WBC) ≥ 2,000 cells/µL * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 * Platelets ≥ 100,000 cells/mm3 * Hemoglobin ≥ 8.0 g/dL; Note: The use of transfusion or other interventions to achieve Hgb ≥ 8.0 g/dL is acceptable * Adequate renal function within 30 days prior to registration, defined as follows: * Serum creatinine \< 1.5 mg/dL or creatinine clearance (CrCl) ≥ 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \[(140 - age) x (weight in kg)\] / \[(Serum Cr mg/dL) x (72)\] CrCl female = 0.85 x (CrCl male) * Patients with serum creatinine \> 1.5 mg/dL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman * Adequate hepatic function within 30 days prior to registration, defined as follows: * Bilirubin \< 2 mg/dL * AST or ALT \< 3 x the upper limit of normal * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential. * The subject/legally authorized representative (LAR) must provide study-specific informed consent prior to study entry. Exclusion Criteria: * All nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies. * Any N3 patients * Any prior radiotherapy to the head and neck region. * Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\&N cancer is permissible. * Prior chemotherapy or radiotherapy within the last three years. * Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes). * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%. * Subjects with simultaneous primary cancers outside of the oropharynx o Note: Exceptions can be made for patients with simultaneous primaries outside the H\&N if determined by the PI/Co-PI that the patient can proceed with protocol activities. * Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding. * Severe, active co-morbidities defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. * Transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration. * 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
6 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 @ 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 Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can immunotherapy before surgery stop early oral cancer from returning?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Can a glowing dye show surgeons where head and neck tumors end?
- Re-irradiation plus cetuximab targets head and neck tumors that return