Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06607406
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Accelerated radiotherapy — RADIATION
    6 fractions per week, BID fractions one day per week
  • Conventional radiotherapy — RADIATION
    5 fractions per week, daily M-F

Study Details

The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.

Key Dates

Start date
Jan 21, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional fractionation (5 Fractions)
    5 fractions per week, daily treatment Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care
  • Experimental: Accelerated fractionation (6 Fractions)
    6 fractions per week, daily treatment plus twice daily treatment for 1 day Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care

Primary Outcome Measure

Locoregional Recurrence-free Survival [ Time Frame: 2 years post radiotherapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Levine Cancer InstituteCharlotteNorth Carolina28204
Matthew Ward, MD
[email protected]
(980)442-1100
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Ryan Hughes, MD
[email protected]
(336) 713-6575
Advocate Aurora Radiation OncologyMilwaukeeWisconsin53215
Jeffrey Kittel, MD
[email protected]
414-649-6420

Find similar trials in Charlotte, NC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Levine Cancer Institute· Charlotte, NCWake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NCAdvocate Aurora Radiation Oncology· Milwaukee, WI

Related Studies