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

March 29, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Hypofractionated Radiotherapy
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.
Radiation: Hypofractionated Radiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years after completion of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 2 years
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.
From enrollment to 2 years
2-Year Overall Survival (OS)
Time Frame: From enrollment to 2 years
Overall survival defined as time from enrollment to death from any cause.
From enrollment to 2 years
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.
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 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.
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 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.
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 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.
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 body weight assessed in kilograms (kg) from baseline to each follow-up time point.
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 serum albumin levels assessed in grams per liter (g/L) from baseline to each follow-up time point.
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
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.
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
Proportion of participants who require temporary interruption or permanent discontinuation of radiotherapy due to adverse events or other reasons.
During the 3-week radiotherapy treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ye Zhang, MD, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25/173-0173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

Data will become available within 6 months after publication of the primary results and will be available for up to 5 years following publication.

IPD Sharing Access Criteria

Access to IPD will be granted to qualified researchers who submit a methodologically sound research proposal. Requests should be sent to the Principal Investigator (drzye1983@163.com). A data use agreement must be signed before data are released. Data will be provided in a de-identified format to protect participant privacy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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