RecruitingPhase 2NCT04444869

Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer

Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx "ENID"


Sponsor

University of Missouri-Columbia

Enrollment

28 participants

Start Date

Sep 28, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lower doses of radiation therapy combined with chemotherapy work just as well as standard doses for people with low-risk HPV-related oropharyngeal cancer (throat cancer caused by the HPV virus, usually affecting the tonsil or base of tongue). **You may be eligible if...** - You have been diagnosed with HPV-positive oropharyngeal squamous cell carcinoma (throat cancer related to HPV) - Your cancer is classified as low-risk (typically stage I or II under newer staging systems) - You are medically fit enough to receive chemotherapy and radiation **You may NOT be eligible if...** - Your cancer is in the mouth, lip, larynx (voice box), or nasopharynx — even if HPV-positive - You have had prior radiation to the head and neck - You have significant kidney, liver, or hearing problems that prevent certain chemotherapy - You are pregnant or breastfeeding 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

DRUGCisplatin injection

Standard dose cisplatin given concurrently with radiation therapy


Locations(1)

University of Missouri

Columbia, Missouri, United States

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NCT04444869


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