Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma

Официальное название

Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial

Обзор

This study aims to evaluate the safety and efficacy of hypofractionated radiotherapy in patients with postoperative intermediate-risk head and neck squamous cell carcinoma.

Подробное описание

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period of up to 28 days to determine eligibility for study entry. Eligible patients will then receive hypofractionated radiotherapy (PGTVtb/PGTVnd-tb: 45 Gy in 15 fractions of 3.0 Gy; PTV1: 40.5 Gy in 15 fractions of 2.7 Gy, once daily, 5 days per week for 3 weeks.).

Вмешательства

• Лучевая терапия Hypofractionated Radiotherapy
  Hypofractionated radiotherapy: 45 Gy in 15 fractions (3.0 Gy/fraction) to PGTVtb/PGTVnd-tb and 40.5 Gy in 15 fractions (2.7 Gy/fraction) to PTV1, once daily, 5 days per week for 3 weeks.

Первичные конечные точки

• Incidence of Grade ≥3 Late Toxicity at 2 Years [Срок оценки: Up to 2 years after completion of radiotherapy]

Вторичные конечные точки (11)

• 2-Year Disease-Free Survival (DFS) [Срок оценки: From enrollment to 2 years]
• 2-Year Locoregional Control (LRC) [Срок оценки: From enrollment to 2 years]
• 2-Year Overall Survival (OS) [Срок оценки: From enrollment to 2 years]
• Incidence and Severity of Acute Adverse Events [Срок оценки: From start of radiotherapy to 90 days post-treatment]
• Change in EORTC Head and Neck Cancer Module (QLQ-H&N35) Score [Срок оценки: Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Change in M.D. Anderson Dysphagia Inventory (MDADI) Score [Срок оценки: Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Change in EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) Score [Срок оценки: Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Change in Body Weight [Срок оценки: Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Change in Serum Albumin Level [Срок оценки: Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score [Срок оценки: Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Rate of Radiotherapy Interruption or Discontinuation [Срок оценки: During the 3-week radiotherapy treatment period]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Histologically or cytologically confirmed stage II-IVA head and neck squamous cell carcinoma (AJCC 8th edition), including oral cavity, oropharynx, hypopharynx, larynx, or cervical lymph node metastasis from unknown primary
• R0 resection and standard neck dissection per surgical evaluation
• Negative surgical margins and no extranodal extension in metastatic lymph nodes on postoperative pathology
• Presence of at least one intermediate-risk factor: close margins (<5 mm), pT3-4, pN2, lymphovascular invasion, perineural invasion, poor differentiation, or for oral cavity cancer T2 with depth of invasion >5 mm
• Adequate organ function (without blood transfusion or growth factors within 14 days):
• White blood cell count ≥ 2.0 × 10\^9/L
• Absolute neutrophil count ≥ 1.0 × 10\^9/L
• Platelet count ≥ 80 × 10\^9/L
• Hemoglobin ≥ 90 g/L
• Willing and able to comply with study and follow-up procedures
• Voluntary participation with written informed consent

Критерии исключения

• Prior radiotherapy or surgery to the head and neck region
• Primary head and neck cancer arising from other sites such as paranasal sinuses, nasopharynx, glottic larynx, skin, or salivary glands
• Concurrent other anti-tumor therapy
• Prior neoadjuvant drug therapy
• Evidence of tumor progression on imaging within 28 days before enrollment
• History of severe infection within 1 month before enrollment, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia; any active infection, or unexplained fever >38.5°C during screening or before first dose
• Severe cardiovascular disease: grade II or higher myocardial ischemia or infarction, uncontrolled arrhythmia (including QTc interval ≥450 ms for males or ≥470 ms for females); New York Heart Association (NYHA) class III-IV heart failure, or left ventricular ejection fraction (LVEF) ≤50% on echocardiography
• History of other malignancy within 5 years (except adequately treated in situ cervical cancer or basal cell/squamous cell carcinoma of the skin)
• History of psychoactive substance abuse that cannot be abstained from, or mental disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07507058 · 25/173-0173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗