RecruitingNot ApplicableNCT06630780

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

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

Sponsor

Sun Yat-sen University

Enrollment

50 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

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 Criteria4

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

Interventions

RADIATIONHead 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.