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

Official title

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

Overview

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

Detailed description

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.).

Interventions

• Radiation 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.

Primary outcome measures

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

Secondary outcome measures (11)

• 2-Year Disease-Free Survival (DFS) [Time frame: From enrollment to 2 years]
• 2-Year Locoregional Control (LRC) [Time frame: From enrollment to 2 years]
• 2-Year Overall Survival (OS) [Time frame: From enrollment to 2 years]
• Incidence and Severity of Acute Adverse Events [Time frame: From start of radiotherapy to 90 days post-treatment]
• Change in EORTC Head and Neck Cancer Module (QLQ-H&N35) Score [Time frame: 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 [Time frame: 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 [Time frame: Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Change in Body Weight [Time frame: Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment]
• Change in Serum Albumin Level [Time frame: 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 [Time frame: 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 [Time frame: During the 3-week radiotherapy treatment period]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07507058 · 25/173-0173

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗