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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Locoregional Control (LRC) Rate
기간: 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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- HypoRT in Older HNSCC Patients
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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