Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma (REPORT-HNSCC)

A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
• Intervention / Treatment: Radiation: Head and Neck Cancers

Detailed Description

In order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase II study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Yan Chen; Phone Number: 86 020-87342926; Email: chenchuny@sysucc.org.cn
• Study Contact Backup: Name: Ya-Ni Zhang; Phone Number: 86 020-87342926; Email: zhangyn1@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, China
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Chun-Yan Chen, Prof.; Phone Number: 020-87342926; Email: chenchuny@sysucc.org.cn
      • Contact: Ya-Ni Zhang, Dr.; Phone Number: 020-87342926; Email: zhangyn1@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma
• Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the IV/V region with imaging diagnosis or biopsy confirmation before surgery. HPV/ P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node > 3cm or multiple positive cervical lymph nodes before surgery
• The pathology of at least one cervical lymph node was determined by pCR；
• Karnofsky's physical status score ≥70 points；
• Age: 18 ~ 70 years old；
• Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 75×109/L
• Patients participate voluntarily and sign informed consent forms.

Exclusion Criteria:

• Previous head and neck radiation treatment
• Severe complications；
• Pregnant or lactating women
• Who were deemed unsuitable for inclusion by the researchers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Trial Group; All patients received intensity-modulated conformal radiotherapy (IMRT). To ensure study quality, all IMRT plans were reviewed by the research team at Sun Yat-sen University Cancer Center. The delineation principles for the radiotherapy target volume of the primary tumor bed and normal tissues followed the consensus guidelines. (1) Tumor bed (CTVtb): It was delineated based on the tumor extent shown in laryngoscopy, enhanced CT/MRI, or PET CT before induction therapy49. For patients with significant anatomical changes due to tumor regression, the CTVtb was adjusted, taking into account the patient's anatomy after induction chemotherapy and the initial state of the tumor; if a cavity appeared due to tumor regression, it was adjusted according to natural anatomical boundaries.(2) High-risk clinical target volume (CTV1): CTVtb plus a 5-10mm margin, with a prescribed dose of at least 60Gy in 30 fractions. (3) Low-risk clinical target volume (CTV2): CTV1 plus a 5-10mm margin. For hypo

Radiation: Head and Neck Cancers; All patients received intensity-modulated conformal radiotherapy (IMRT). To ensure study quality, all IMRT plans were reviewed by the research team at Sun Yat-sen University Cancer Center. The delineation principles for the radiotherapy target volume of the primary tumor bed and normal tissues followed the consensus guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year region-free recurrence survival (RRFS)	Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause	2-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Defined as documented treatment progression or death from any cause.	2-year
Distant metastasis-free survival (DMFS)	Defined as documented distant metastases or death from any cause	2-year
Overall survival (OS)	Defined as a documented death due to any cause or last follow-up; regional recurrence pattern; and acute and late toxicity.	2-year
Local recurrence-free survival (LRFS)	Defined as documented primary tumor recurrence or death from any cause	2-year
Acute and Late Radiation Injuries	The acute radiation toxicity was assessed using the CTCAE 5.0 version, while the RTOG and EORTC late radiation toxicity scales were used to evaluate late toxicity.	Day 1 of radiotherapy to 2 years post-treatment
Quality of life assessment	The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for the Head and Neck Cancer Module (QLQ-H&N35) version 1.0.	Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.
Quality of life assessment	The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).	Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Liu-Wei Tang, The Ethics Committee of the Center for Cancer Prevention and Treatment, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; HNSCC; Adjuvant Radiotherapy; Radiation dose reduction; Post-radical surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 2023-FXY-224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data supporting this study's findings are available from the PI (Chun-Yan Chen) upon reasonable request.
• IPD Sharing Time Frame: Commencing from the publication date of papers related to this study, with no end date.
• IPD Sharing Access Criteria: Data will be collected using a case record form (CRF). The PI will securely maintain all trial records, CRFs, and study-related documents for ten years in the study office before archiving them in the Medical Records section. Access will be provided to the PI, CIs, and IEC with the appropriate permissions. The PI will also be responsible for overseeing communication with the IEC and DSMU to ensure ethical oversight and participant safety.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No