Robotic surgery may spare throat cancer patients from chemo and radiation

NCT ID NCT05419089

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether robotic surgery alone can control HPV-related throat cancer, potentially sparing patients the long-term side effects of chemotherapy and radiation. The study enrolls people with HPV-positive oropharyngeal cancer whose tumors are removable and who have no detectable cancer DNA in their blood after surgery. Researchers are asking whether this less intensive approach can achieve survival rates similar to standard therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transoral robotic surgery (TORS)
What this could lead to
If successful, this could allow some patients with HPV-related throat cancer to avoid chemotherapy and radiation, reducing long-term side effects while maintaining cancer control.
What could go wrong
This is a relatively small phase 2 trial, and it is not yet known whether surgery alone will be as effective as standard therapy. There is a risk of cancer recurrence without additional 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 83 people

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

Started

Jul 2022

Expected to finish

Jun 2029

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: * Patients must have histologically or cytologically confirmed and identified resectable primary OPSCC with positive p16 immunohistochemistry, defined as strong and diffuse nuclear and cytoplasmic staining in \> 70% of tumor cells. Immunohistochemistry must be performed or reviewed at the central laboratory. P16 status may be determined prior to consent and must be confirmed by surgical specimen if a biopsy is unavailable. HR-HPV status and postoperative cfHPVDNA testing must be performed and resulted prior to treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery. * Patients enrolled in the trial must have pre-surgery baseline cfHPVDNA using the NavDX assay (Naveris, Cambridge, MA). Detectable baseline cfHPVDNA copy number is defined as ≥ 10 fragments/mL and is required for inclusion in the trial. * Undetectable cfHPVDNA after surgery. All patients should have a repeat cfHPVDNA test within 1 to 5 weeks post-operatively and prior to treatment assignment. Undetectable cfHPVDNA is defined as \< 5 fragments/mL. * AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal extension. * Age ≥ 18 years at screening * No previous surgery, radiation therapy, or chemotherapy for head and neck cancer (other than excision/incisional biopsy of the primary site, excisional/incisional nodal biopsy, or tonsillectomy) is allowed at time of study entry. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * No active tobacco use (≥1cigarette or cigarette-equivalent per day within the last 5 years) and no cumulative smoking history of \>20 pack years. 1 cigar = 4 cigarette-equivalent exposure * Ability to understand and the willingness to sign a written informed consent document. * Participants must have adequate bone marrow, hepatic and renal functions as defined below: * Platelet count ≥ 90 x 109/l. * Hemoglobin ≥ 10 g/dl (may achieve by transfusion). * Renal function: eGFR ≥ 50 ml/min Exclusion Criteria * Age \< 18 years at screening * Pregnant or breast-feeding women. * Previous or current malignancies at other sites, except for adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, prostate cancer treated with surgery/radiotherapy, ductal carcinoma in situ of the breast treated with surgery/radiotherapy, or other cancer curatively treated and with no current evidence of disease for at least 3 years. * Other serious illnesses or medical conditions including but not limited to: * Unstable cardiac disease despite treatment or myocardial infarction within 6 months prior to study entry. * History of significant neurologic or psychiatric disorders including severe dementia or poorly controlled seizures * Active clinically significant uncontrolled infection * Active peptic ulcer disease defined as unhealed or clinically active * Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis * Severe chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia within 12 months of diagnosis. * Prior organ transplant * Interstitial lung disease * Concurrent treatment with any other anti-cancer therapy * Participation in an investigational therapeutic drug trial within 30 days of study entry. Participation in additional investigational radiation studies will exclude participation in SIRS. Participation in non-therapeutic, non-oncologic investigational studies (i.e. pain control studies, nutritional studies, etc.) will be allowed amongst SIRS participants, provided there is no alteration of treatment planning, oncologic therapy, or surveillance, and additional studies comply with SIRS safety criteria and stopping rules as outlined in the SIRS protocol. * Active hepatitis C by history * Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, unequivocal radiographic or clinical supraclavicular or matted metastatic disease, \> 3 unequivocally radiographic pathologic cervical nodes. * Non-HR-HPV subtype on initial biopsy or final pathology. * 5 or more positive nodes, irrespective of size, on final pathology. * p16 or HPV negative OPSCC as determined by IHC and PCR or ISH, respectively. * Undetectable or \< 10 fragments/mL baseline cfHPVDNA prior to surgery. * Autoimmune disease treated with chemotherapy agents or anti TNF agents within the last 2 years. * Detectable repeat cfHPVDNA 1-5 weeks postoperatively via the NavDX assay, defined as \> 5 fragments/mL.

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mount Sinai Health System

    RECRUITING

    New York, New York, 10019, United States

  • Valley - Mount Sinai Comprehensive Cancer Care

    RECRUITING

    Paramus, New Jersey, 07652, United States

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