RecruitingPhase 2NCT06167291

Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)


Sponsor

M.D. Anderson Cancer Center

Enrollment

240 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To test a new radiation treatment design based on where your cancer is located. Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck. However, for participants with oropharyngeal cancer on one side of the neck, receiving radiation to both sides of the neck may result in increased side effects and radiation exposure. This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized imaging technique called lymphoscintigraphy — which maps nearby lymph nodes — to guide more precise surgery and radiation treatment for early-stage throat cancers linked to HPV. The goal is to treat only the lymph nodes that actually need treatment, reducing side effects. **You may be eligible if...** - You have a newly diagnosed HPV-positive cancer at the base of the tongue or tonsil - Your cancer is early stage (T1-T2, N0-N1) and does not cross the midline of your throat - You are over 18 years old - You have no signs of cancer spread to the far side of your neck or to distant organs - You have not yet received chemotherapy or surgery for this cancer **You may NOT be eligible if...** - You have previously had head or neck cancer (other than small skin cancers) - You have had prior radiation to the head and neck area - You have cancer that has spread to distant parts of the body - You are pregnant or not using effective contraception - You have a known allergy to iodine or the injection agent used in the imaging - You have active scleroderma, lupus, or similar autoimmune disease that would make radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONArm 1- Ipsilateral

Given by I-RT


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06167291