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NCT Number: NCT07507058

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

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

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated radiotherapy

Radiation

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 outcomes

  1. Incidence of Grade ≥3 Late Toxicity at 2 Years

    Time frame: 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 outcomes

  1. 2-Year Disease-Free Survival (DFS)

    Time frame: 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. 2-Year Locoregional Control (LRC)

    Time frame: 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.

  3. 2-Year Overall Survival (OS)

    Time frame: From enrollment to 2 years

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

  4. Incidence and Severity of Acute Adverse Events

    Time frame: 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.

  5. 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 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.

  6. 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 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.

  7. 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 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.

  8. 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 body weight assessed in kilograms (kg) from baseline to each follow-up time point.

  9. 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 serum albumin levels assessed in grams per liter (g/L) from baseline to each follow-up time point.

  10. 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

    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.

  11. Rate of Radiotherapy Interruption or Discontinuation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pinfei Pan

CONTACT

[email protected]

15607421631

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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