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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Omar Mahmoud
Study ID
NCT06309225
Status
Recruiting
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Conditions

  • Frailty
  • Oropharynx Cancer

Eligibility Criteria

Sex
ALL
Age
65 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Modified dose and fields intensity modulated radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Cisplatin: 30-40 mg/m2/week, every week during radiation. Dose should be based on actual body weight. The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment. Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) are mandatory for this study. 55 Gy radiation in 5 weeks using 5 fractions per week + Cisplatin every week

Primary Outcome Measure

Two-year progression free survival [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207
Clinical Trials and Translational Medicine Divsion
[email protected]

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By research site
Baptist MD Anderson Cancer Center· Jacksonville, FL

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