Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer

A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation

Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer (NCT05800574) is a Phase 2 interventional studying Oropharynx Cancer, sponsored by Fox Chase Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Oropharynx Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 22 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Pathologically confirmed squamous cell carcinoma of the oropharynx - Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below): - Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3 (cranial nerve III) with no contralateral neck adenopathy - Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and/or by the treating radiation oncologist or a head and neck surgeon - CT with contrast and/or MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please contact the study PI - PET/CT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy. - Immunohistochemical staining for p16 that demonstrates moderate to severe staining in at least 70% of cells. - Patients must provide their smoking history prior to registration. Number of pack-years = \[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\]/20 - Patients must have clinically and/or radiographically evident disease that can be accurately measured in accordance with RECIST criteria v. 1.1. - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56 days prior to registration - Age ≥ 18 years. - Adequate hematologic function within 14 days prior to registration - Adequate renal function within 14 days prior to registration - Adequate hepatic function within 14 days prior to registration Who Should NOT Join This Trial: - Tumors that cross midline, regardless of T stage - N2 adenopathy (bilateral neck adenopathy) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Pathologically confirmed squamous cell carcinoma of the oropharynx * Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below): * Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3 (cranial nerve III) with no contralateral neck adenopathy * Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and/or by the treating radiation oncologist or a head and neck surgeon * CT with contrast and/or MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please contact the study PI * PET/CT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy. * Immunohistochemical staining for p16 that demonstrates moderate to severe staining in at least 70% of cells. * Patients must provide their smoking history prior to registration. Number of pack-years = \[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\]/20 * Patients must have clinically and/or radiographically evident disease that can be accurately measured in accordance with RECIST criteria v. 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56 days prior to registration * Age ≥ 18 years. * Adequate hematologic function within 14 days prior to registration * Adequate renal function within 14 days prior to registration * Adequate hepatic function within 14 days prior to registration Exclusion Criteria: * Tumors that cross midline, regardless of T stage * N2 adenopathy (bilateral neck adenopathy) * Gross total excision of the primary site in a diagnostic procedure prior to either imaging and/or physical examination by registering physician. * p16-negative squamous cell carcinoma * Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles * Prior systemic therapy for the study cancer * Prior head and neck cancer surgery that involved the neck (includes excisional biopsy) * Prior radiation therapy to the head and neck that would result in overlap of treated fields * History of allergic reaction attributed to Technetium-99m-tilmanocept used in lymphoscintigraphy * Uncontrolled intercurrent illness including, but not limited to, any other malignancy, other ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breast feeding

Treatments Being Tested

RADIATION

Radiation therapy (5 days for 7 weeks)

Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)

RADIATION

Radiation therapy (5 days for 6 weeks)

Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks )

DRUG

Cisplatin

Cisplatin, 40mg/m2 (weekly for 7 weeks)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05800574), the sponsor (Fox Chase Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05800574 clinical trial studying?

This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05800574?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05800574?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Related Oropharynx Cancer Trials

Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer

Phase 2 · University of Missouri-Columbia

Source: ClinicalTrials.gov API v2 record for NCT05800574. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05800574. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.