RecruitingNot ApplicableNCT06309225

Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly

Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)


Sponsor

Omar Mahmoud

Enrollment

20 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less. For this reason this study is looking at a different regimen of reducing the intensity of the treatment. The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.


Eligibility

Min Age: 65 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether older adults (65 and up) with HPV-related throat cancer (oropharynx cancer) can be treated with reduced doses of chemotherapy alongside radiation, to lessen serious side effects while still achieving good cancer control. HPV-positive throat cancer generally responds well to treatment, which may allow dose reductions in older patients. **You may be eligible if...** - You are 65 years or older - You have been diagnosed with squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or throat walls) that is HPV-related (p16 positive) - Your cancer is stage T1-T3, N1-N2, with no distant spread (M0) - Your blood counts and organ function (kidneys, liver) are within normal ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have already received radiation or chemotherapy for a prior cancer - Your cancer has returned after previous treatment - You have an autoimmune disease or uncontrolled HIV - Your overall health makes your life expectancy less than 1 year 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

RADIATIONModified dose and fields intensity modulated radiotherapy

Instead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach.


Locations(1)

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

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NCT06309225


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