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

NCT07847060 | Not Yet Recruiting

• 1 other identifier: HypoRT in Older HNSCC Patients
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Head and Neck; Head and Neck Neoplasms

Keywords

Hypofractionated radiotherapy; Hypofractionation; IMRT; VMAT; Older adults; Geriatric oncology; Radiation-induced toxicity; Normofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Locoregional Control (LRC) Rate

  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

Study Arms (2)

Hypofractionated Radiotherapy

EXPERIMENTAL

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

Standard Normofractionated Radiotherapy

ACTIVE COMPARATOR

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

Interventions

Hypofractionated Radiotherapy RADIATION

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.

Hypofractionated Radiotherapy

Normofractionated Radiotherapy RADIATION

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.

Standard Normofractionated Radiotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09