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

NCT ID NCT01706939

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a lower dose of radiation to the standard dose for people with HPV-positive throat cancer. The goal is to see if the lower dose can control the cancer just as well while causing fewer side effects. The trial involves 23 participants with advanced but non-spread cancer.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

23 people

The number who actually took part.

Started

Sep 2012

Expected to finish

May 2035

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: * Participants must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, unknown primary, or nasopharynx that is HPV positive as determined by PCR and p16 positive as determined by IHC. Tissue from the primary site must be available for biomarker studies. PCR and IHC must be performed in the central laboratory (Zhang, MSSM) * Stage 3 or 4 disease without evidence of distant metastases. * At least one clinically evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria. * Age \> 18 years. * No previous surgery, radiation therapy or chemotherapy for SSCHN (other than biopsy or tonsillectomy) is allowed at time of study entry. * ECOG performance status of 0 or 1. * No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity). * Participants must have adequate bone marrow, hepatic and renal functions as defined in the protocol. * Ability to understand and the willingness to sign a written informed consent document. * Patients with Gilbert's Disease and absent hepatic pathology by history and clinical assessment maybe treated on study with bilirubins \> the ULN for the institution if other liver function studies are within the normal range Exclusion Criteria: * Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter. * Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years. * Symptomatic peripheral neuropathy ≥ grade 2 by NCI Common Terminology Criteria (NCI-CTC) version 4. * Symptomatic altered hearing \> grade 2 by NCI-CTCv4 criteria. * Other serious illnesses or medical conditions including but not limited to: 1. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry 2. History of significant neurologic or psychiatric disorders including dementia or seizures 3. Active clinically significant uncontrolled infection 4. Active peptic ulcer disease defined as unhealed or clinically active 5. Hypercalcemia 6. Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis 7. Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor 8. Autoimmune disease requiring therapy, prior organ transplant, or HIV infection 9. Interstitial lung disease 10. Hepatitis C (test required) * Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry. * Concurrent treatment with any other anticancer therapy. * Participation in an investigational therapeutic drug trial within 30 days of study entry. * Active smoking within the past 20 years with a cumulative Pack Year history of \> 20 Pack Years or active smoking (Defined as \> 1 cigarette per day) within the last 2 years

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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

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.