Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Hypofractionated Radiotherapy, Postoperative Radiotherapy, HNSCC
Brief summary
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
RADIATIONHypofractionated 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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade ≥3 Late Toxicity at 2 Years | Up to 2 years after completion of radiotherapy | Proportion of participants with grade 3 or higher late adverse events related to radiotherapy, assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Late toxicity is defined as adverse events occurring more than 90 days after completion of radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-Year Disease-Free Survival (DFS) | From enrollment to 2 years | Disease-free survival defined as time from enrollment to first occurrence of disease progression (locoregional recurrence or distant metastasis) or death from any cause, whichever occurs first. Disease progression is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| 2-Year Locoregional Control (LRC) | From enrollment to 2 years | Locoregional control defined as time from enrollment to locoregional recurrence (recurrence at the primary tumor site or regional lymph nodes), assessed according to RECIST version 1.1. |
| 2-Year Overall Survival (OS) | From enrollment to 2 years | Overall survival defined as time from enrollment to death from any cause. |
| Incidence and Severity of Acute Adverse Events | From start of radiotherapy to 90 days post-treatment | Number of participants experiencing adverse events during or within 90 days after completion of radiotherapy, graded according to NCI-CTCAE version 5.0. All adverse events, regardless of relationship to radiotherapy, will be recorded and summarized by type, frequency, and severity. |
| Change in EORTC Head and Neck Cancer Module (QLQ-H&N35) Score | Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment | Change from baseline in head and neck cancer-specific symptoms and quality of life assessed by the European Organization for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-H\&N35). Scores are transformed to a 0-100 scale. According to the study protocol scoring method, higher scores indicate better quality of life. |
| Change in M.D. Anderson Dysphagia Inventory (MDADI) Score | Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment | Change from baseline in swallowing-related quality of life assessed by the M.D. Anderson Dysphagia Inventory (MDADI). The total score ranges from 20 to 100, with higher scores indicating better swallowing function and quality of life. The scale includes Global (1 item), Emotional (6 items), Functional (5 items), and Physical (8 items) subscales. |
| Change in EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment | Change from baseline in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 V3.0). Scores are transformed to a 0-100 scale according to the EORTC scoring manual. For global health status and functional scales, higher scores indicate better quality of life/function. For symptom scales, higher scores indicate worse symptoms. |
| Change in Body Weight | Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment | Change in body weight assessed in kilograms (kg) from baseline to each follow-up time point. |
| Change in Serum Albumin Level | Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment | Change in serum albumin levels assessed in grams per liter (g/L) from baseline to each follow-up time point. |
| Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score | Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment | Change in nutritional status assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) score. The PG-SGA consists of two sections: a patient-completed medical history (weight, food intake, symptoms, activities and function) and a professional-completed physical examination and metabolic stress score. Scores range from 0 to 35 or higher, with higher scores indicating worse nutritional status (higher symptom burden and greater need for nutrition intervention). A score ≥9 typically indicates critical need for nutrition intervention. |
| Rate of Radiotherapy Interruption or Discontinuation | During the 3-week radiotherapy treatment period | Proportion of participants who require temporary interruption or permanent discontinuation of radiotherapy due to adverse events or other reasons. |
Contacts
CONTACTPinfei Pan
PRINCIPAL_INVESTIGATORYe Zhang, MD
Chinese Academy of Medical Sciences
Outcome results
None listed