Study on Using Lymphoscintigraphy to Guide Neck Radiation for p16+ Oropharynx Cancer with Favorable Risk

Sponsor: Fox Chase Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05800574

Provider View

This clinical trial is exploring a new approach to treating p16+ oropharynx cancer by using lymphoscintigraphy to guide radiation therapy to the neck. The study aims to improve outcomes for patients with a favorable prognosis by targeting radiation to specific areas.

Patient Parameters

Program Overview

The purpose of this study is to test a new method of directing radiation therapy for patients with p16+ oropharynx cancer, which affects the throat area. The study uses a technique called lymphoscintigraphy to map the lymph nodes in the neck and guide radiation treatment to the affected side. This approach is being tested in patients with either no lymph node involvement or cancerous lymph nodes on one side of the neck. The study will monitor the progression of cancer on the opposite side of the neck using PET/CT scans and assess side effects like dry mouth over time. Participants will receive treatment for 6-7 weeks unless they experience severe side effects or choose to stop. The study will track disease-free survival and overall survival for up to 24 months after treatment.

Description

This study is testing a new way to treat p16+ oropharynx cancer by using a special imaging technique called lymphoscintigraphy to guide radiation therapy to the neck. Patients who test positive for p16 will be asked to join the study during their initial treatment planning. The study will focus on patients with cancer that has not spread to both sides of the neck. Radiation will be directed to the side of the neck where cancer is present, and the opposite side will be monitored for any changes using PET/CT scans. The study will also measure side effects like dry mouth at 6, 12, and 24 months. Participants will receive treatment for 6-7 weeks, unless they experience severe side effects or decide to withdraw. The study will evaluate how long patients remain free of cancer and their overall survival for up to 24 months after treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oropharynx.
  • Cancer must be on one side of the neck and not cross the midline.
  • Tumor stage T1-2, close to but not crossing the midline.
  • Recent CT or MRI scans showing no cancer spread to both sides of the neck.
  • Recent PET/CT scan showing no cancer spread to both sides of the neck.
  • Positive p16 test with moderate to severe staining in at least 70% of cells.
  • Provide smoking history before joining the study.
  • Cancer that can be measured according to specific criteria.
  • ECOG performance status of 0-1, indicating good overall health.
  • Age 18 or older.
  • Adequate blood, kidney, and liver function based on recent tests.

Exclusion Criteria

  • Tumors that cross the midline.
  • Cancer spread to both sides of the neck.
  • Major surgery to remove the primary cancer site before imaging or examination.
  • Negative p16 test.
  • Evidence of cancer spread beyond the neck or below the collarbones.
  • Previous systemic therapy for the current cancer.
  • Previous head and neck surgery involving the neck.
  • Previous radiation therapy to the head and neck that overlaps with current treatment areas.
  • Allergic reaction to Technetium-99m-tilmanocept used in lymphoscintigraphy.
  • Uncontrolled illnesses, including other cancers, infections, heart failure, unstable heart conditions, or psychiatric issues that affect study participation.
  • Pregnant or breastfeeding women.

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