Recruiting
Phase 2

Lymphoscintigraphy Directed Radiation

Sponsor:

Fox Chase Cancer Center

Code:

NCT05800574

Conditions

Oropharynx Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation therapy (5 days for 7 weeks)

Radiation therapy (5 days for 6 weeks)

Cisplatin

Study Details

Brief 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.

Conditions

Oropharynx Cancer

Study ID

NCT05800574

Start date

Mar 14, 2023

Status verified date

May, 2026

Completion date

Sep 23, 2027

Anticipated

Primary completion date

Sep 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A (>N1 or single node > 3cm )

More 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).

experimental: Cohort B (N0 or N1 <3cm)

For Cohort B patients need to have either no lymph nodes or only one lymph node adenopathy, provided it is smaller than 3cm.

Interventions

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 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 )

Cisplatin

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

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 ]

Central Contacts and Locations

Central contacts

Ryan Romasko

2678388380ryan.romasko@fccc.edu

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Thomas Galloway, MD

215-728-4300thomas.galloway@fccc.edu

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2026-05-22.