HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04580446
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated intensity modulated radiotherapy — RADIATION
    Hypofractionated intensity modulated radiotherapy with concurrent chemotherapy (weekly cisplatin)

Study Details

This is a single arm Phase I study of de-intensified hypofractionated radiation therapy for favorable human papilloma virus-associated oropharynx cancer. It will evaluate the tolerability of a de-intensified hypofractionated radiation therapy regimen completed in 3 weeks (with equivalent biologically effective dose to 60 Gy in 30 fractions) with concurrent weekly cisplatin.

Key Dates

Start date
Dec 3, 2020
Status verified
Nov 2025
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)
    Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week

Primary Outcome Measure

Maximally Tolerated Dose/Fractionation of Hypofractionated Radiation Therapy [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Texas Southwestern Medical Center· Dallas, TX

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