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

NCT07507058 | Not Yet Recruiting

• 1 other identifier: 25/173-0173
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Hypofractionated Radiotherapy; Postoperative Radiotherapy; HNSCC

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 years after completion of radiotherapy

Secondary Outcomes (11)

• 2-Year Disease-Free Survival (DFS)

  From enrollment to 2 years

• 2-Year Locoregional Control (LRC)

  From enrollment to 2 years

• 2-Year Overall Survival (OS)

  From enrollment to 2 years

• Incidence and Severity of Acute Adverse Events

  From start of radiotherapy to 90 days post-treatment

• Change in EORTC Head and Neck Cancer Module (QLQ-H&N35) Score

  Baseline, end of radiotherapy, and at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post-treatment

Study Arms (1)

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.

Radiation: Hypofractionated Radiotherapy

Interventions

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.

Experimental: Hypofractionated Radiotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Ye Zhang, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinfei Pan

CONTACT

15607421631; PPF0521@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.