Could less radiation be just as effective for HPV throat cancer?

NCT ID NCT03323463

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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 316 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2017

Expected to finish

Oct 2026

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

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

  • Baptist Alliance MCI (Data Collection Only)

    Miami, Florida, 33143, United States

  • Hartford Healthcare (Data Collection)

    Hartford, Connecticut, 06102, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Rockville Centre

    Rockville Centre, New York, 11570, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

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