Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

NCT ID: NCT06630780

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-26
• Study Completion Date: 2029-12-31

Brief Summary

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.

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Head and Neck Cancers

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Chen Chunyan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liu-Wei Tang

Role: STUDY_DIRECTOR

The Ethics Committee of the Center for Cancer Prevention and Treatment, Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chun-Yan Chen

Role: CONTACT

chenchuny@sysucc.org.cn

020-87342926 ext. 86

Ya-Ni Zhang

Role: CONTACT

zhangyn1@sysucc.org.cn

020-87342926 ext. 86

Facility Contacts

Chun-Yan Chen, Prof.

Role: primary

chenchuny@sysucc.org.cn

020-87342926

Ya-Ni Zhang, Dr.

Role: backup

zhangyn1@sysucc.org.cn

020-87342926

Other Identifiers

2023-FXY-224

Identifier Type: -

Identifier Source: org_study_id