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

NCT05800574 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 22-1031HN-107
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (7)

• Level of xerostomia

  2 years

• Mean swallowing change (modified barium swallowing test)

  2 years

• Mean swallowing change (patient reported)

  2 years

• Rate of contralateral neck progression

  2 years

• Overall survival (OS)

  2 years

Study Arms (2)

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

EXPERIMENTAL

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).

Radiation: Radiation therapy (5 days for 7 weeks); Drug: Cisplatin

Cohort B (N0 or N1 <3cm)

EXPERIMENTAL

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

Radiation: Radiation therapy (5 days for 6 weeks)

Interventions

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 )

Cohort B (N0 or N1 <3cm)

Cisplatin DRUG

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

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

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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Cardinal Health: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Thomas Galloway, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Romasko

CONTACT

2678388380; ryan.romasko@fccc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 5, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)