Hypofractionated Radiotherapy in Older Adults With Head and Neck Squamous Cell Carcinoma

September 23, 2026 updated by: Nada Mohamed Sayed Hussein, Assiut University

Clinical Outcomes and Toxicity of Hypofractionated Radiotherapy in Older Adults With Head and Neck Squamous Cell Carcinoma

Standard radiotherapy for head and neck squamous cell carcinoma typically requires daily treatments over 6 to 7 weeks. For older adults, these prolonged treatment schedules can cause substantial physical fatigue, travel burden, and treatment interruptions. Hypofractionated radiotherapy delivers higher doses of radiation per session over a shorter total treatment time (approximately 3 weeks), potentially limiting tumor cell regrowth, easing logistical demands on patients, and improving completion rates.

The purpose of this randomized controlled trial is to evaluate the clinical effectiveness, safety, and toxicity of hypofractionated radiotherapy compared with standard normofractionated radiotherapy in older adults with non-metastatic head and neck squamous cell carcinoma.

Eligible participants aged 65 years and older will be randomly assigned in a 1:1 ratio to receive either:

  • Hypofractionated Radiotherapy (Intervention): External beam radiotherapy delivered via image-guided intensity-modulated techniques (IMRT/VMAT) once daily over approximately 3 weeks (45 Gy in 15 fractions for definitive therapy, or 40.5 Gy in 15 fractions for postoperative/adjuvant therapy).
  • Standard Normofractionated Radiotherapy (Comparator): External beam radiotherapy delivered once daily using conventional fractionation schedules over approximately 6 to 7 weeks according to institutional clinical standards.

Participants will be monitored weekly during radiation treatment and followed for up to 1 year post-treatment. The primary outcome is locoregional control, with secondary outcomes assessing overall survival, disease-free survival, acute and late toxicities graded by CTCAE version 6.0, and health-related quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck.
  • Age ≥ 65 years.
  • Non-metastatic disease (M0).
  • Early-stage or locally advanced disease considered suitable for definitive or postoperative radiotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • Adequate baseline organ function to safely undergo radiotherapy (including adequate hematological, renal, and hepatic function according to institutional criteria).
  • No prior radiation therapy delivered to the head and neck region.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Presence of distant metastases (M1) at enrollment.
  • ECOG performance status > 2.
  • Severe uncontrolled comorbidities that make radiotherapy unsafe.
  • Inability to comply with treatment planning, immobilization, or protocol follow-up requirements.
  • Refusal or inability to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated Radiotherapy

Eligible older adults receive hypofractionated external beam radiotherapy using image-guided intensity-modulated radiotherapy (IMRT/VMAT). For definitive radiotherapy, a total dose of 45 Gy in 15 fractions (3 Gy per fraction) will be administered once daily, 5 fractions per week, over approximately 3 weeks. For postoperative/adjuvant radiotherapy, a total dose of 40.5 Gy in 15 fractions (2.7 Gy per fraction) will be administered once daily, 5 fractions per week, over approximately 3 weeks.
Radiation: Hypofractionated Radiotherapy

External beam radiotherapy administered using image-guided intensity-modulated radiotherapy (IMRT/VMAT) techniques. In the definitive setting, patients receive a total dose of 45 Gy in 15 fractions (3 Gy per fraction), delivered once daily, 5 fractions per week over approximately 3 weeks. In the postoperative/adjuvant setting, patients receive a total dose of 40.5 Gy in 15 fractions (2.7 Gy per fraction), delivered once daily, 5 fractions per week over approximately 3 weeks.
Active Comparator: Standard Normofractionated Radiotherapy

Eligible older adults receive standard normofractionated external beam radiotherapy according to institutional clinical practice guidelines (conventional fractionation, typically 1.8-2.0 Gy per fraction once daily, 5 fractions per week over 6-7 weeks) for definitive or postoperative head and neck squamous cell carcinoma.
Radiation: Normofractionated Radiotherapy

Standard external beam radiotherapy administered according to institutional protocols using conventional fractionation schedules (1.8-2.0 Gy per fraction, once daily, 5 fractions per week over 6-7 weeks) for definitive or postoperative management of head and neck squamous cell carcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional Control (LRC) Rate
Time Frame: 1 year after completion of radiotherapy

Locoregional control is defined as the proportion of participants without evidence of persistent, recurrent, or progressive tumor at the primary disease site or regional cervical lymph nodes, assessed via clinical examination and diagnostic imaging.
1 year after completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

September 23, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

September 29, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HypoRT in Older HNSCC Patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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