Could less radiation be just as effective for HPV throat cancer?
NCT ID NCT03323463
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a much lower dose of radiation (30 Gy) combined with standard chemotherapy works as well as the usual high dose (70 Gy) for people with HPV-positive throat cancer. The goal is to reduce long-term side effects while still controlling the cancer. About 316 participants are being enrolled, and the study is currently in Phase 2.
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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 316 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2017
- Expected to finish
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Oct 2026
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: \- Cohort A: Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from surgical resection or excisional biopsy regardless of margin status. * Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) and consent from the PI or co-PIs * Cohort B: Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls). Surgical removal of primary site is no longer required. * Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) and consent from the PI or co-PIs * Subjects must have clinically or radiographically evident measurable disease at nodal stations. * Clinical stage T1-2, N1-2c without evidence of distant metastasis based on FDG PET/CT. * Patients who have squamous cell carcinoma of the neck of unknown primary, and thus, are T0, are allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI * 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 Karnopsky Performance Status \>/= 50 * Age ≥ 18 * Adequate hematologic function within 30 days prior to registration, defined as follows: * White Blood Count (WBC) \>/= 2 K/mcL * 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 intervention 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 (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) * 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 must provide study-specific informed consent prior to study entry Exclusion Criteria: * Subjects with prior head and neck radiation therapy * Subjects with simultaneous primary cancers outside of the oropharynx * 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 * No particle therapy such as but not limited to proton therapy is allowed in Cohort A. For Cohort B, this exclusion is removed. * Severe, active co-morbidity 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.
Contacts and locations
Locations
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Baptist Alliance MCI (Data Collection Only)
Miami, Florida, 33143, United States
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Hartford Healthcare (Data Collection)
Hartford, Connecticut, 06102, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could less radiation be enough for HPV throat cancer?