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Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

NCT04284540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-02-03

No results posted yet for this study

Summary

The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers in patients 70 years of age and older.

Standard radiation treatment for head and neck patients normally requires that the patient travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. If this happens, and there are gaps in the radiation treatment, this can lead to worse outcomes.

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

RADIATION

Adjuvant hypofractionation

15 fractions of 2.7 Gy per fraction daily over 3 weeks for a total of 40.5 Gy to the post-operative bed and/or necks.

RADIATION

Definitive Hypofractionation

15 fractions of 3 Gy per fraction daily over 3 weeks for a total of 45 Gy to regions of gross disease. Elective areas can be treated to 37.5 Gy in 15 fractions.

Sponsors & Collaborators

Principal Investigators

  • Richard L. Bakst, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2024-11-07
Completion
2025-06-12

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284540 on ClinicalTrials.gov