Head and Neck Squamous Cell CarcinomaNCT07507058
Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma
A study testing Hypofractionated Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Hypofractionated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial
This study aims to evaluate the safety and efficacy of hypofractionated radiotherapy in patients with postoperative intermediate-risk head and neck squamous cell carcinoma.
Read the 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.).
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Hypofractionated Radiotherapy
- Keywords
- Hypofractionated Radiotherapy, Postoperative Radiotherapy, HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Hypofractionated Radiotherapy | Experimental | 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. Receives: Radiation: Hypofractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years after completion of radiotherapy
Secondary outcomes (11)
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.
Measured: 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.
Measured: From enrollment to 2 years
2-Year Overall Survival (OS)
Overall survival defined as time from enrollment to death from any cause.
Measured: 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.
Measured: From start of radiotherapy to 90 days post-treatment
Change in EORTC Head and Neck Cancer Module (QLQ-H&N35) Score
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.
Measured: Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment
Change in M.D. Anderson Dysphagia Inventory (MDADI) Score
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.
Measured: Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment
Change in EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) Score
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.
Measured: Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment
Change in Body Weight
Change in body weight assessed in kilograms (kg) from baseline to each follow-up time point.
Measured: Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment
Change in Serum Albumin Level
Change in serum albumin levels assessed in grams per liter (g/L) from baseline to each follow-up time point.
Measured: Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment
Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score
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.
Measured: Baseline, weekly during radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment
Rate of Radiotherapy Interruption or Discontinuation
Proportion of participants who require temporary interruption or permanent discontinuation of radiotherapy due to adverse events or other reasons.
Measured: During the 3-week radiotherapy treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ye Zhang, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507058
- Sponsor's protocol ID
- 25/173-0173
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared with other researchers upon reasonable request. The data to be shared include de-identified participant data related to the study outcomes, including demographic data, efficacy outcomes (DFS, LRC, OS), safety data (adverse events), and quality of life assessments (EORTC QLQ-C30, QLQ-H\&N35, MDADI).
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07507058
- Acronym / sponsor ID
- 25/173-0173
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Hypofractionated Radiotherapy, Postoperative Radiotherapy, HNSCC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Hypofractionated Radiotherapy | Experimental | Radiation: Hypofractionated RadiotherapyPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated RadiotherapyHypofractionated 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. | Radiation | Experimental: Hypofractionated Radiotherapy |
Primary outcome
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.
11 secondary outcomes
2-Year Disease-Free Survival (DFS)
Time frame: From enrollment to 2 years
2-Year Locoregional Control (LRC)
Time frame: From enrollment to 2 years
2-Year Overall Survival (OS)
Time frame: From enrollment to 2 years
Incidence and Severity of Acute Adverse Events
Time frame: From start of radiotherapy to 90 days post-treatment
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 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 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 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 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 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
Rate of Radiotherapy Interruption or Discontinuation
Time frame: During the 3-week radiotherapy treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared with other researchers upon reasonable request. The data to be shared include de-identified participant data related to the study outcomes, including demographic data, efficacy outcomes (DFS, LRC, OS), safety data (adverse events), and quality of life assessments (EORTC QLQ-C30, QLQ-H\&N35, MDADI).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ye Zhang, MD principal investigator
Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pinfei Pan (15607421631, PPF0521@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥3 Late Toxicity at 2 Years (time frame: Up to 2 years after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.