Hypofractionated Radiotherapy in Older Adults With Head and Neck Squamous Cell Carcinoma
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
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. |
|
Aktivní komparátor: 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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Locoregional Control (LRC) Rate
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HypoRT in Older HNSCC Patients
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .