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

N/ANot Yet RecruitingNCT07507058

Cancer Institute and Hospital, Chinese Academy of Medical Sciences60 enrolled

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.

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.).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Hypofractionated RadiotherapyRADIATION

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Grade ≥3 Late Toxicity at 2 Years

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.

Time frame: Up to 2 years after completion of radiotherapy

Secondary Outcomes

2-Year Disease-Free Survival (DFS)

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.

Time frame: From enrollment to 2 years

2-Year Locoregional Control (LRC)

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.

Time frame: From enrollment to 2 years

2-Year Overall Survival (OS)

Overall survival defined as time from enrollment to death from any cause.

Time frame: From enrollment to 2 years

Incidence and Severity of Acute Adverse Events

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.

Time frame: From start of radiotherapy to 90 days post-treatment

Change in EORTC Head and Neck Cancer Module (QLQ-H&N35) Score

Central Contacts

Pinfei Pan

CONTACT

15607421631 PPF0521@163.com

Data from ClinicalTrials.gov

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