Clinical trial · Interventional
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
NCT07507058CI-TRIAL-00107184not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the safety and efficacy of hypofractionated radiotherapy in patients with postoperative intermediate-risk head and neck squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Hypofractionated Radiotherapy
- description
- Patients receive hypofractionated radiotherapy: PGTVtb/PGTVnd-tb 45 Gy in 15 fractions of 3.0 Gy, and PTV1 40.5 Gy in 15 fractions of 2.7 Gy, once daily, 5 days per week for 3 weeks.
- interventionNames
- Radiation: Hypofractionated Radiotherapy
Primary outcomes (1)
- measure
- Incidence of Grade ≥3 Late Toxicity at 2 Years
- timeFrame
- Up to 2 years after completion of radiotherapy
- description
- 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 (11)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.