RecruitingNot ApplicableNCT06902623

Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy

A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy

Sponsor

Georgetown University

Enrollment

30 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

HPV Tonsil Cancer Oropharyngeal Cancers Base of Tongue Cancer

Summary

The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a reduced-intensity (de-escalated) radiation therapy approach is as effective as standard chemoradiation for patients with HPV- or p16-positive oropharyngeal cancer (throat cancer linked to the HPV virus), which typically has a better prognosis. **You may be eligible if...** - You are 18 or older - You have confirmed HPV-positive or p16-positive squamous cell cancer of the oropharynx (including the base of tongue, tonsils, soft palate, or throat walls) - Your cancer is clinical stage I or II (T1-2 N1 or T3 N0-1 per AJCC 8th edition) - Your treatment plan includes definitive chemoradiation (not surgery as the primary treatment) **You may NOT be eligible if...** - You have previously received radiation to the head or neck - You have another active cancer that could affect treatment or assessment - You have severe medical conditions that make you unable to tolerate chemoradiation - You are pregnant 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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