AzTrials
AzTrials

Oropharynx CancerPhase 2NCT05800574

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

A Phase 2 study testing Radiation therapy (5 days for 7 weeks), Radiation therapy (5 days for 6 weeks) and Cisplatin in people with Oropharynx Cancer, run by Fox Chase Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharynx Cancer
What is being tested?
Radiation therapy (5 days for 7 weeks), Radiation therapy (5 days for 6 weeks) and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
14 Mar 2023to 23 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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 cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan Romasko contact

2678388380

ryan.romasko@fccc.edu

United States1 site, 1 recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Thomas Galloway, MD, 215-728-4300, thomas.galloway@fccc.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

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. Patients positive for p16 status will be approached for consent during the pre-treatment intake process. Contralateral neck progression will be measured by PET (positron emission tomography)/CT scans. Xerostomia will be measured by the EORTC QLQ (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) H\&N35 at 6, 12, and 24 months. Patients will remain on study treatment for 6-7 weeks or until unacceptable toxicity or withdrawal of consent. Disease free survival (DFS) and overall survival (OS) will be assessed until 24 months after completion of study treatment

Being tested
Radiation therapy (5 days for 7 weeks), Radiation therapy (5 days for 6 weeks), Cisplatin
Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation therapy (5 days for 7 weeks)Radiation

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

  • Radiation therapy (5 days for 6 weeks)Radiation

    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 )

  • CisplatinDrug

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

Study groups in NCT05800574
Study groupRoleWhat they receive
Cohort A (>N1 or single node > 3cm )ExperimentalMore extensive neck involvement or proximity to the midline can qualify a patient in cohort A. Cohort A will have patients with either more than one lymph node adenopathy or 1 lymph node that is large (>3cm).
Receives: Radiation: Radiation therapy (5 days for 7 weeks); Drug: Cisplatin
Cohort B (N0 or N1 <3cm)ExperimentalFor Cohort B patients need to have either no lymph nodes or only one lymph node adenopathy, provided it is smaller than 3cm.
Receives: Radiation: Radiation therapy (5 days for 6 weeks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment

    To evaluate the development of cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment.

    Measured: 1 year

Secondary outcomes (7)

  1. Level of xerostomia

    To evaluate whether the omission of elective radiation to the contralateral neck decrease patient reported xerostomia at 6, 12, and 24 months to a mean score of 47.2 (from an expected 57.2) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35

    Measured: 2 years

  2. Mean swallowing change (modified barium swallowing test)

    To evaluate the functional swallowing change of patients treated with unilateral neck radiation as measured by a modified barium swallow for the period of one year after the end of radiotherapy. The investigators will use summary statistics such as changes in means and changes in proportions to evaluate the functional swallowing change of patients treated with unilateral neck radiation as measured by a modified barium swallow test.

    Measured: 2 years

  3. Mean swallowing change (patient reported)

    To evaluate patient reported swallowing of patients treated with unilateral neck radiation as measured by the EORTC QLQ H\&N 35 for the period of two years after the end of radiotherapy. The investigators will use summary statistics to characterize changes in means of reported swallowing for patients treated with unilateral neck radiation as measured by the EORTC QLQ H\&N 35. The investigators will use sign-rank tests to investigate if the changes are equal to zero.

    Measured: 2 years

  4. Rate of contralateral neck progression

    To evaluate the development of cancer on the contra-lateral side of the neck within 24 months of completion of radiation treatment. The investigators will use cumulative incidence curves and Fine and Gray proportional hazards regressions to characterize the rate of contralateral neck progression for the period of 2 years after the completion of radiation. In this analysis, death will be considered a competing risk.

    Measured: 2 years

  5. Overall survival (OS)

    To evaluate the OS of head and neck cancer patients treated with unilateral neck radiation for the period of two years after the end of radiotherapy using Kaplan Meier curves and Cox proportional hazards regressions.

    Measured: 2 years

  6. Disease free survival (DFS)

    To evaluate the DFS in accordance with RECIST 1.1 of head and neck cancer patients treated with unilateral neck radiation for the period of two years after the end of radiotherapy using Kaplan Meier curves and Cox proportional hazards regressions.

    Measured: 2 years

  7. Dosimetric degree of normal tissue avoidance

    To quantify the dosimetric degree of normal tissue avoidance of unilateral neck radiation when compared to bilateral neck radiation using Wilcoxon Rank-Sum tests

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2023
  2. Study start14 Mar 2023
  3. Primary completion23 Mar 2027 (estimated)
  4. Study completion23 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800574
Sponsor's protocol ID
22-1031
Other IDs
HN-107
Status last verified
Oct 2026
First submitted
24 Mar 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation therapy (5 days for 7 weeks), Radiation therapy (5 days for 6 weeks) and Cisplatin in people with Oropharynx Cancer, run by Fox Chase Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryan Romasko (2678388380, ryan.romasko@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05800574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in