Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05800574

Lymphoscintigraphy Guided Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer A Phase II Study with Primary (Chemo) Radiation

Led by Fox Chase Cancer Center · Updated on 2024-12-24

22

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

Sponsors

F

Fox Chase Cancer Center

Lead Sponsor

C

Cardinal Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a treatment approach for patients with p16-positive oropharynx cancer who have a favorable prognosis. This phase II, prospective study focuses on patients with either no lymph node involvement or malignant neck adenopathy limited to one side of the neck as confirmed by lymphoscintigraphy mapping. The study aims to assess outcomes including cancer progression on the opposite side of the neck within one year after radiation treatment. Participants will receive radiation therapy delivered on weekdays over either 6 or 7 weeks, totaling 35 treatment sessions. Some patients will also receive weekly doses of the drug cisplatin during the 7-week radiation schedule. The radiation targets only the affected side of the neck, guided by lymphoscintigraphy results. Treatment continues until completion, unacceptable side effects, or withdrawal of consent. During the study, participants will undergo assessments including PET/CT scans to monitor for cancer progression on the contralateral neck. Quality of life related to dry mouth symptoms will be measured at 6, 12, and 24 months using a standardized questionnaire. Researchers will also track disease-free and overall survival for up to 24 months following treatment. Patients remain on study treatment for 6 to 7 weeks, with ongoing monitoring after completion.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed squamous cell carcinoma of the oropharynx
  • Patients planned for bilateral neck radiation per guidelines must have either no nodes or limited nodes on the same side without contralateral neck adenopathy
  • Tumor stage T1-2 approaching within 1 cm but not crossing the midline
  • CT or MRI with contrast within 56 days before enrollment showing no bilateral neck adenopathy
  • PET/CT within 28 days before enrollment showing no bilateral neck adenopathy
  • p16 staining showing moderate to severe staining in at least 70% of cells
  • Smoking history provided before enrollment
  • Clinically or radiographically measurable disease per RECIST v1.1
  • ECOG performance status 0-1 within 56 days before enrollment
  • Age 18 years or older
  • Adequate blood, kidney, and liver function within 14 days before enrollment
Not Eligible

You will not qualify if you...

  • Tumors crossing the midline at any T stage
  • Bilateral neck adenopathy (N2)
  • Complete removal of primary site before imaging or exam by registering physician
  • p16-negative squamous cell carcinoma
  • Clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
  • Prior systemic therapy for this cancer
  • Prior head and neck surgery involving the neck
  • Prior radiation to the head and neck overlapping study fields
  • Allergy to Technetium-99m-tilmanocept
  • Uncontrolled illnesses including other cancers, active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
  • Pregnant or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

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Research Team

R

Ryan Romasko

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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