Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

NCT06630780 | Recruiting DMC

• 1 other identifier: 2023-FXY-224
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Keywords

HNSCC; Post-radical surgery; Adjuvant Radiotherapy; Radiation dose reduction; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Progression-free survival (PFS)

  2-year

• Distant metastasis-free survival (DMFS)

  2-year

• Overall survival (OS)

  2-year

• Local recurrence-free survival (LRFS)

  2-year

• Acute and Late Radiation Injuries

  Day 1 of radiotherapy to 2 years post-treatment

Study Arms (1)

Trial Group

EXPERIMENTAL

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

Interventions

Head and Neck Cancers 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.

Trial Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous head and neck radiation treatment
• Severe complications；
• Pregnant or lactating women

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Study Officials

• Liu-Wei Tang

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

  STUDY DIRECTOR

Central Study Contacts

Chun-Yan Chen

CONTACT

020-87342926; chenchuny@sysucc.org.cn

Ya-Ni Zhang

CONTACT

020-87342926; zhangyn1@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Phase II trial

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: October 8, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Commencing from the publication date of papers related to this study, with no end date.
• 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.

Locations

CN (1)