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NCT07507058Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
15 Mar 2026
Start date
1 Apr 2026
Primary completion date
1 Apr 2029
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT07507058

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Apr 2026 to the primary completion date, 1 Apr 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior radiotherapy or surgery to the head and neck region
  • 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

Other illness

  • Primary head and neck cancer arising from other sites such as paranasal sinuses, nasopharynx, glottic larynx, skin, or salivary glands
  • 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

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.